US10864080B2 - Distal anchor apparatus and methods for mitral valve repair - Google Patents

Abstract

In some embodiments, an apparatus includes a handle, an actuator, a pusher device, and a puncture member. A distal anchor is disposed at a distal end portion of an artificial chorda, or suture, and is in a delivery configuration. The artificial chorda, or suture, is coupled to the actuator and extends through a lumen of the puncture member. The actuator can be actuated to move the puncture member distally a preset distance, and to move the pusher device distally such that at least a portion of the distal anchor is moved distal to the distal end of the puncture member and the distal anchor is moved from its delivery configuration to a deployed configuration.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of International Application No. PCT/US2016/055170, filed on Oct. 3, 2016, which claims the benefit of U.S. Application No. 62/315,879, filed on Mar. 31, 2016; and U.S. Application No. 62/236,225, filed on Oct. 2, 2015, all of the disclosures of which are incorporated herein by reference in their entireties.

BACKGROUND

Some embodiments described herein relate to methods and apparatus for performing cardiac valve repairs, and more particularly, methods and apparatus for performing minimally invasive mitral or tricuspid valve repairs.

Various disease processes can impair the proper functioning of one or more of the valves of the heart. These disease processes include degenerative processes (e.g., Barlow's Disease, fibroelastic deficiency), inflammatory processes (e.g., Rheumatic Heart Disease), and infectious processes (e.g., endocarditis). Additionally, damage to the ventricle from prior heart attacks (i.e., myocardial infarction secondary to coronary artery disease) or other heart diseases (e.g., cardiomyopathy) can distort the valve's geometry causing it to dysfunction. However, the vast majority of patients undergoing valve surgery, such as mitral valve surgery, suffer from a degenerative disease that causes a malfunction in a leaflet of the valve, which results in prolapse and regurgitation.

Generally, a heart valve may malfunction in two different ways. One possible malfunction, valve stenosis, occurs when a valve does not open completely and thereby causes an obstruction of blood flow. Typically, stenosis results from buildup of calcified material on the leaflets of the valves causing them to thicken and thereby impairing their ability to fully open and permit adequate forward blood flow.

Another possible malfunction, valve regurgitation, occurs when the leaflets of the valve do not close completely thereby causing blood to leak back into the prior chamber. There are three mechanisms by which a valve becomes regurgitant or incompetent; they include Carpentier's type I, type II and type III malfunctions. A Carpentier type I malfunction involves the dilation of the annulus such that the area of the valve orifice increases. The otherwise normally functioning leaflets do not have enough surface area to cover the enlarged orifice and fail to form a tight seal (i.e., do not coapt properly) causing regurgitation. Included in a type I mechanism malfunction are perforations of the valve leaflets, as in endocarditis. A Carpentier's type II malfunction involves prolapse of a segment of one or both leaflets above the plane of the annulus. This is the most common cause of mitral regurgitation, and is often caused by the stretching or rupturing of chordae tendineae normally connected to the leaflet. A Carpentier's type III malfunction involves restriction of the motion of one or more leaflets such that the leaflets are abnormally constrained below the level of the plane of the annulus. Leaflet restriction can be caused by rheumatic disease (IIIa) or dilation of the ventricle (IIIb).

Mitral valve disease is the most common valvular heart disorder, with nearly 4 million Americans estimated to have moderate to severe mitral valve regurgitation (“MR”). MR results in a volume overload on the left ventricle which in turn progresses to ventricular dilation, decreased ejection performance, pulmonary hypertension, symptomatic congestive heart failure, atrial fibrillation, right ventricular dysfunction and eventually death. Successful surgical mitral valve repair restores mitral valve competence, abolishes the volume overload on the left ventricle, improves symptom status, prevents adverse left ventricular remodeling and dramatically improves life expectancy, often returning it to that of a normal member of the population.

Malfunctioning valves may either be repaired or replaced. Repair typically involves the preservation and correction of the patient's own valve. Replacement typically involves replacing the patient's malfunctioning valve with a biological or mechanical substitute. Typically, replacement is preferred for stenotic damage sustained by the leaflets because the stenosis is irreversible. The mitral valve and tricuspid valve, on the other hand, are more prone to deformation. Deformation of the leaflets, as described above, prevents the valves from closing properly and allows for regurgitation or back flow from the ventricle into the atrium, which results in valvular insufficiency. Deformations in the structure or shape of the mitral valve or tricuspid valve are often repairable.

In mitral valve regurgitation, repair is preferable to valve replacement. Mitral valve replacement operations have a 2× higher risk of operative mortality (Risk Standardized Mortality 1.65% vs 2.96%), 2× higher risk of stroke per year (1.15%±0.1% vs 2.2%±0.4%) and a 10× higher risk of infection per year (0.1% vs 1.0%). Patients who receive a quality mitral valve repair operation do not require anticoagulation and rarely require reoperation. This is in stark contrast to mechanical valve replacement which mandates lifelong anticoagulation and bioprosthetic valve replacement with the eventual certainty of prosthetic valve dysfunction and reoperation. Compared to mitral valve replacement, mitral valve repair results in improved left ventricular function and has superior long term survival. Therefore, an improperly functioning mitral valve or tricuspid valve is ideally repaired, rather than replaced. However, because of the complex and technical demands of the repair procedures, the mitral valve is still replaced in approximately one third of all mitral valve operations performed in the United States.

Studies suggest that Carpentier type II malfunction, often referred to as “Degenerative,” “Primary” or “Organic” MR, accounts for as much as 60% of MR. Resectional mitral valve repair techniques, initially described by Dr. Carpentier, involve cutting out (resecting) a section of the prolapsed leaflet tissue, stitching the remaining tissue together and implanting an annuloplasty ring around the annulus. More recently many surgeons have moved to a “non-resectional” repair technique where artificial chordae tendineae (“neochords”) made of ePTFE suture, or another suitable material, are placed in the prolapsed leaflet and secured to the heart in the left ventricle, normally to the papillary muscle. Because the native leaflet tissue is maintained in non-resectional repairs, they often result in a larger surface of coaptation between the posterior and anterior mitral valve leaflets, but properly sizing the neochords on a flaccid heart can be very challenging, especially for the low volume mitral valve surgeon.

Carpentier type I malfunction, sometimes referred to as “Secondary” or “Functional” MR, is associated with heart failure and affects between 1.6 and 2.8 million people in the United States alone. Studies have shown that mortality doubles in patients with untreated mitral valve regurgitation after myocardial infarction. Unfortunately, there is no gold standard surgical treatment paradigm for functional MR and most functional MR patients are not referred for surgical intervention due to the significant morbidity, risk of complications and prolonged disability associated with cardiac surgery. Surgeons use a variety of approaches ranging from valve replacement to insertion of an undersized mitral valve annuloplasty ring for patients suffering from functional MR and the long term efficacy is still unclear. Dr. Alfieri has demonstrated the benefit of securing the midpoint of both leaflets together creating a double orifice valve in patients with MR known as an “Edge-to-Edge” repair or an Alfieri procedure. The ability to combine a neochordal repair with an edge-to-edge repair in degenerative MR patients with a dilated annulus and who do not receive an annuloplasty ring because the repair is done in a minimally-invasive, off-pump procedure, has particular promise.

Regardless of whether a replacement or repair procedure is being performed, conventional approaches for replacing or repairing cardiac valves are typically invasive open-heart surgical procedures, such as sternotomy or thoracotomy, which require opening up of the thoracic cavity so as to gain access to the heart. Once the chest has been opened, the heart is bypassed and stopped. Cardiopulmonary bypass is typically established by inserting cannulae into the superior and inferior vena cavae (for venous drainage) and the ascending aorta (for arterial perfusion), and connecting the cannulae to a heart-lung machine, which functions to oxygenate the venous blood and pump it into the arterial circulation, thereby bypassing the heart. Once cardiopulmonary bypass has been achieved, cardiac standstill is established by clamping the aorta and delivering a “cardioplegia” solution into the aortic root and then into the coronary circulation, which stops the heart from beating. Once cardiac standstill has been achieved, the surgical procedure may be performed. These procedures, however, adversely affect almost all of the organ systems of the body and may lead to complications, such as strokes, myocardial “stunning” or damage, respiratory failure, kidney failure, bleeding, generalized inflammation, and death. The risk of these complications is directly related to the amount of time the heart is stopped (“cross-clamp time”) and the amount of time the subject is on the heart-lung machine (“pump time”).

Thus, there is a significant need to perform mitral valve repairs using less invasive procedures while the heart is still beating. Accordingly, there is a continuing need for new procedures and devices for performing cardiac valve repairs, such as mitral valve repair, which are less invasive, do not require cardiac arrest, and are less labor-intensive and technically challenging.

SUMMARY

Apparatus and methods for performing a non-invasive procedure to repair a cardiac valve are described herein. In some embodiments, devices to deliver a distal anchor within the atrium of the heart are described herein. Such a device can include a handle, an actuator operably coupled to the handle, a pusher device, a puncture member coupled to the actuator and at least partially disposed within a lumen defined by the pusher device, and a distal anchor. The distal anchor is disposed at a distal end portion of an artificial chorda and disposed in a delivery configuration. The artificial chorda has a proximal end portion coupled to the actuator. The proximal end portion of the artificial chorda extends through a lumen defined by the puncture member. The actuator can be actuated to move the puncture member distally a preset distance, and to move the pusher device distally such that at least a portion of the distal anchor is moved distal to the distal end of the puncture member and the distal anchor is moved from its delivery configuration to a deployed configuration.

BRIEF DESCRIPTION OF THE DRAWINGS

Various embodiments are depicted in the accompanying drawings for illustrative purposes, and should in no way be interpreted as limiting the scope of the inventions. In addition, various features of different disclosed embodiments can be combined to form additional embodiments, which are part of this disclosure. Throughout the drawings, reference numbers may be reused to indicate correspondence between reference elements.

FIG. 1 is a cut-away anterior view of a heart, showing the internal chambers, valves and adjacent structures.

FIG. 2A is a top perspective view of a healthy mitral valve with the mitral leaflets closed.

FIG. 2B is a top perspective view of a dysfunctional mitral valve with a visible gap between the mitral leaflets.

FIG. 2C is a cross-sectional view of a heart illustrating a mitral valve prolapsed into the left atrium.

FIG. 2D is an enlarged view of the prolapsed mitral valve ofFIG. 2C.

FIG. 3 is a cross-sectional view of a heart showing the left atrium, right atrium, left ventricle, right ventricle and the apex region.

FIG. 4 is a schematic illustration of a delivery device, according to an embodiment, shown inserted into a portion of a heart.

FIG. 5 is a schematic illustration of two anchor-tether apparatus shown implanted within a heart, according to an embodiment.

FIG. 6 is a schematic illustration of a distal anchor delivery device, according to an embodiment, shown in a first configuration prior to deployment of a distal anchor through a mitral leaflet of a heart and showing the lumen of the outer tube and the lumen of the pusher device.

FIG. 7 is a schematic illustration of the distal anchor delivery device ofFIG. 6, shown in a first configuration during deployment of a distal anchor through a mitral leaflet of a heart.

FIG. 8 is a schematic illustration of the distal anchor delivery device ofFIG. 6, shown in a second configuration during deployment of a distal anchor.

FIG. 9 is a schematic illustration of the distal anchor delivery device ofFIG. 6, shown in a third configuration showing formation of the distal anchor during deployment.

FIG. 10 is a schematic illustration of the distal anchor delivery device ofFIG. 6, shown in a fourth configuration showing the delivery device being retracted after deployment of the distal anchor.

FIG. 11 is a perspective view of the distal anchor ofFIG. 6 shown in an elongated coiled configuration and disposed about the needle of the delivery device.

FIG. 12 is a side view of the distal anchor ofFIG. 6, shown in a coiled knot configuration.

FIG. 13A is a side view of a single coil/loop variation of the distal anchor ofFIG. 6 shown in an elongated coiled configuration;FIG. 13B is a side view of the single coil/loop variation of the distal anchor ofFIG. 13A in a partially coiled knot configuration; andFIG. 13C is a side view of the single coil/loop variation of the distal anchor ofFIG. 13A in a coiled knot configuration.

FIG. 14A is a schematic illustration of a side view of a distal anchor delivery device according to another embodiment, shown in a first configuration prior to deployment of a distal anchor through a mitral leaflet of a heart.

FIG. 14B is a schematic illustration of a side view of the distal anchor delivery device ofFIG. 14A, shown in a second configuration during deployment of a distal anchor through a mitral leaflet of a heart.

FIG. 14C is a schematic illustration of a side view of the distal anchor delivery device ofFIG. 14A, shown in a third configuration during deployment of a distal anchor.

FIG. 14D is a schematic illustration of a side view of the distal anchor delivery device ofFIG. 14A, shown in a fourth configuration during deployment of the distal anchor.

FIG. 14E is a schematic illustration of a side view of the distal anchor delivery device ofFIG. 14A, shown in a fifth configuration as the delivery device is being retracted after deployment of the distal anchor.

FIG. 15A is a cross-sectional side view of a distal anchor delivery device, according to another embodiment.

FIG. 15B is an enlarged cross-sectional side view of a portion of the distal anchor delivery device ofFIG. 15A.

FIG. 15C is a perspective view of a distal end portion of the delivery device ofFIG. 15A

FIG. 15D is a perspective view of a proximal end portion of the delivery device ofFIG. 15A showing a suture catch of the delivery device in an open position.

FIG. 16 is a perspective view shown partially in cross-section of the distal anchor delivery device ofFIG. 15A, shown in a first configuration prior to deployment of a distal anchor through a mitral leaflet of a heart.

FIG. 17A is a perspective view shown partially in cross-section of the distal anchor delivery device ofFIG. 15A, shown in a second configuration during deployment of a distal anchor.

FIG. 17B is a side view of a distal end portion of the delivery device ofFIG. 15A, shown with the distal anchor in a first configuration.

FIG. 18A is a perspective view shown partially in cross-section of the delivery device ofFIG. 15A, shown during deployment of a distal anchor.

FIG. 18B is a side view of a distal end portion of the delivery device ofFIG. 15A, shown with the distal anchor in a first configuration.

FIG. 19A is a perspective view shown partially in cross-section of the delivery device ofFIG. 15A, shown in a third configuration.

FIG. 19B is a side view of a distal end portion of the delivery device ofFIG. 15A, showing formation of the distal anchor into a second configuration during deployment.

FIG. 20A is a perspective view shown partially in cross-section of the anchor delivery device ofFIG. 15A, shown in a fourth configuration showing the delivery device being retracted after deployment of the distal anchor.

FIG. 20B is a side view of a distal end portion of the delivery device ofFIG. 15A, showing the delivery device being retracted after deployment of the distal anchor.

FIG. 21 is a cross-sectional side view the delivery device ofFIG. 15A, showing the pusher hub when released from the plunger during deployment.

FIGS. 22A-22C are a side view, a top view in cross-section, and a side view in cross-section, respectively, of a fluid transfer system of the distal anchor delivery device ofFIG. 15A.

FIGS. 23-27 illustrate delivery and deployment of a distal anchor using the delivery device ofFIG. 15A.

FIG. 28A is a schematic illustration of a side view of a distal anchor delivery device according to another embodiment, shown in a first configuration prior to deployment of a distal anchor through a mitral leaflet of a heart.

FIG. 28B is a schematic illustration of a side view of the distal anchor delivery device ofFIG. 28A, shown in a second configuration during deployment of the distal anchor.

FIG. 28C is a schematic illustration of a side view of the distal anchor delivery device ofFIG. 28A, shown in a third configuration during deployment of the distal anchor.

FIG. 28D is a schematic illustration of a side view of the distal anchor delivery device ofFIG. 28A, shown in a fourth configuration during deployment of the distal anchor.

FIG. 28E is a schematic illustration of a side view of the distal anchor delivery device ofFIG. 28A, shown in a fifth configuration as the delivery device is being retracted after deployment of the distal anchor.

FIG. 29A is a schematic illustration of a side view of a distal anchor delivery device according to another embodiment, shown in a first configuration prior to deployment of a distal anchor through a mitral leaflet of a heart.

FIG. 29B is a schematic illustration of a side view of the distal anchor delivery device ofFIG. 29A, shown in a second configuration during deployment of the distal anchor.

FIG. 29C is a schematic illustration of a side view of the distal anchor delivery device ofFIG. 29A, shown in a third configuration during deployment of the distal anchor.

FIG. 29D is a schematic illustration of a side view of the distal anchor delivery device ofFIG. 29A, shown in a fourth configuration during deployment of the distal anchor.

FIG. 29E is a schematic illustration of a side view of the distal anchor delivery device ofFIG. 29A, shown in a fifth configuration as the delivery device is being retracted after deployment of the distal anchor.

FIG. 30A is a schematic illustration of a side view of a distal anchor delivery device according to another embodiment, shown in a first configuration prior to deployment of a distal anchor through a mitral leaflet of a heart.

FIG. 30B is a schematic illustration of a side view of the distal anchor delivery device ofFIG. 30A, shown in a second configuration during deployment of the distal anchor.

FIG. 30C is a schematic illustration of a side view of the distal anchor delivery device ofFIG. 30A, shown in a third configuration during deployment of the distal anchor.

FIG. 30D is a schematic illustration of a side view of the distal anchor delivery device ofFIG. 30A, shown in a fourth configuration during deployment of the distal anchor.

FIG. 30E is a schematic illustration of a side view of the distal anchor delivery device ofFIG. 30A, shown in a fifth configuration as the delivery device is being retracted after deployment of the distal anchor.

FIG. 31 is a schematic illustration of a distal anchor shown in an elongated configuration, according to an embodiment.

FIGS. 32A-32E illustrate in sequence the formation of the distal anchor ofFIG. 31 about an exterior of a distal end portion of a delivery device, shown in an elongated configuration.

FIGS. 33A-33D illustrate an example procedure for preparing a delivery device to deliver a distal anchor, according to an embodiment.

FIGS. 34A-34H illustrate an example method of forming a distal anchor about an exterior of a needle.

FIG. 35 is a side view of a distal anchor according to another embodiment, shown in a first delivery configuration.

FIG. 36 is a side view of the distal anchor ofFIG. 35 shown in a second deployed configuration.

FIG. 37 is a perspective view of a distal anchor according to another embodiment, shown in a delivery configuration.

FIG. 38A is a side view of a distal anchor according to another embodiment shown in a first delivery configuration.

FIG. 38B is a side view of the distal anchor ofFIG. 38A shown in a second delivery configuration.

FIGS. 38C and 38D illustrate a side view and a perspective view, respectively, of the distal anchor ofFIG. 38A shown in a deployed configuration.

FIG. 39A is a side view of a distal anchor according to another embodiment shown in a delivery configuration;FIG. 39B is a side view of the distal anchor ofFIG. 39A shown in a partially deployed configuration; andFIG. 39C is a side view of the distal anchor ofFIG. 39A in a deployed configuration.

FIG. 40A is a side view of a distal anchor according to another embodiment shown in a delivery configuration;FIG. 40B is a side view of the distal anchor ofFIG. 40A shown in a partially deployed configuration; andFIG. 40C is a side view of the distal anchor ofFIG. 40A in a deployed configuration.

FIG. 41A is a side view of a distal anchor according to another embodiment, shown in a delivery configuration and disposed within a lumen of a delivery device.

FIG. 41B is illustrates the distal anchor ofFIG. 41A in the delivery configuration.

FIG. 41C illustrates the distal anchor ofFIG. 41A in a partially deployed configuration.

FIG. 41D illustrates the distal anchor ofFIG. 41A in a deployed configuration.

FIGS. 42A and 42B illustrate the distal anchor ofFIG. 41A, shown in the deployed configuration.

FIGS. 43A-43C illustrate a distal anchor according to another embodiment, shown in a deployed configuration.

FIG. 44A illustrates a distal anchor according to another embodiment, shown in a delivery configuration.

FIG. 44B illustrates the distal anchor ofFIG. 44A, shown with reference to a valve leaflet and in the delivery configuration.

FIG. 44C illustrates in cross-section the distal anchor ofFIG. 44A, shown in the delivery configuration.

FIG. 44D illustrates the distal anchor ofFIG. 44A, shown with reference to the valve leaflet and in a deployed configuration.

FIG. 44E illustrates in cross-section the distal anchor ofFIG. 44A, shown with reference to the valve leaflet and in the deployed configuration.

FIGS. 45A and 45B are side views of a distal anchor according to another embodiment, shown in a delivery configuration and a deployed configuration, respectively.

FIG. 45C is a perspective view of the distal anchor ofFIGS. 45A and 45B, shown in the deployed configuration.

FIG. 46A illustrates a distal anchor according to another embodiment, shown in a in a delivery configuration.

FIG. 46B is a schematic of the distal anchor ofFIG. 46A, shown in a deployed configuration.

DETAILED DESCRIPTION

The headings provided herein, if any, are for convenience only and do not necessarily affect the scope or meaning of the claimed invention.

Although certain preferred embodiments and examples are disclosed below, inventive subject matter extends beyond the specifically disclosed embodiments to other alternative embodiments and/or uses and to modifications and equivalents thereof. Thus, the scope of the claims that may arise herefrom is not limited by any of the particular embodiments described below. For example, in any method or process disclosed herein, the acts or operations of the method or process may be performed in any suitable sequence and are not necessarily limited to any particular disclosed sequence. Various operations may be described as multiple discrete operations in turn, in a manner that may be helpful in understanding certain embodiments; however, the order of description should not be construed to imply that these operations are order dependent. Additionally, the structures, systems, and/or devices described herein may be embodied as integrated components or as separate components. For purposes of comparing various embodiments, certain aspects and advantages of these embodiments are described. Not necessarily all such aspects or advantages are achieved by any particular embodiment. Thus, for example, various embodiments may be carried out in a manner that achieves or optimizes one advantage or group of advantages as taught herein without necessarily achieving other aspects or advantages as may also be taught or suggested herein.

Apparatus and methods for performing a non-invasive procedure to repair a cardiac valve, such as a mitral valve or tricuspid valve, are described herein. In some embodiments, a method for repairing a mitral valve includes inserting a delivery device through an apex region of a heart and extending a distal end of the delivery device to the proximal side of a leaflet of the mitral valve. A piercing portion of the delivery device can be used to form an opening in the leaflet, through which the distal end of the delivery device can be inserted. The delivery device can be used to form or deliver a distal anchor to the distal side of the leaflet. The location of the opening in the leaflet and the placement of the distal anchor can be anywhere in the leaflet from the free edge up to the base of the mitral valve leaflet and even in the mitral-annular curtain or annulus of the valve. The delivery device can then be withdrawn and a tether coupled to the distal anchor can be secured to an outer surface of the heart at the apex region with, for example, a proximal anchor. The combined distal anchor, tether and proximal anchor is also referred to herein as an anchor-tether apparatus. Before the proximal anchor of the anchor-tether apparatus is fixed to the heart, the length of the tether portion can be adjusted so that the distal movement during systole of the prolapsed segment of the prolapsed leaflet to which the tether portion is coupled by the distal anchor is limited by the tether apparatus during systole. Properly adjusting the length of the anchor-tether apparatus while the heart is beating allows the operator to precisely titrate the position of the prolapsed segment of the prolapsed leaflet in real time to prevent the leaflet from extending above the plane of the annulus (prolapsing), but so that the prolapsed segment of the prolapsed leaflet can move distally during systole a sufficient distance to coapt properly with the other leaflet(s). This adjustment can involve shortening or lengthening the tether portion between the distal and proximal anchors of the anchor-tether apparatus. The same procedure can be repeated on the same leaflet to deliver one or more additional anchor-tether apparatuses to the leaflet, and or can be performed on the other leaflet of the mitral valve to deliver one more anchor-tether apparatuses to the other leaflet (or to both of the other leaflets, in the case of a tricuspid valve). In the case of multiple anchor-tether apparatuses, the tether adjustment procedure can be done one at a time or all at once with the goal of maximizing the surface of coaptation between the leaflets, and eliminating MR.

In some embodiments, a delivery device is provided to perform the above repair procedure. Such a delivery device can include, for example a distal end portion that includes a piercing portion and a support portion, an elongate member coupled to the distal end portion, and an actuating handle coupled to a proximal end portion of the elongate member. The piercing portion of the distal end portion of the delivery device can be used to form the opening in the leaflet of the mitral valve. The support portion of the distal end portion can be used to deliver or form the distal anchor. The handle can include a tether control device that can be used to hold the tether extending from the distal anchor and secure the tether to the apex region with the proximal anchor.

In some embodiments, an apparatus includes a handle, an actuator operably coupled to the handle, a pusher device defining a lumen, a puncture member coupled to the actuator and at least partially disposed within the lumen defined by the pusher device, and a distal anchor. The distal anchor is disposed at a distal end portion of an artificial chorda and disposed in a delivery configuration. The artificial chorda has a proximal end portion coupled to the actuator. The proximal end portion of the artificial chorda extends through a lumen defined by the puncture member. The actuator can be actuated to move the puncture member distally a preset distance and to move the pusher device distally to move the distal anchor distal to the distal end of the puncture member and to move the distal anchor from the delivery configuration to a deployed configuration.

In some embodiments, a method includes inserting a distal end portion of a delivery device through an apex region of a heart, through a ventricle of the heart and to a proximal side of a valve leaflet. The delivery device has a distal anchor disposed in a delivery configuration at a distal end portion of the delivery device. A distal end of the delivery device is positioned in contact with the proximal side of the leaflet of the valve. The delivery device is actuated to move the puncture member distally through the leaflet a preset distance outside the distal end of the delivery device and on a distal side of the leaflet. The puncture member forms, creates or otherwise defines an opening in the leaflet as the puncture member is moved through the leaflet. The distal anchor is disposed at a distal end portion of an artificial chorda. The artificial chorda extends through a lumen of the puncture member and has a proximal end portion coupled to the delivery device. The actuating the delivery device includes moving the distal anchor distally relative to the puncture member to move the distal anchor to a deployed configuration.

In some embodiments, an apparatus includes a handle, an actuator operably coupled to the handle, a pusher device defining a lumen, a puncture member coupled to the actuator and at least partially disposed within a lumen defined by the pusher device, and a distal anchor. The distal anchor is disposed at a distal end portion of an artificial chorda and disposed in a delivery configuration. The artificial chorda has a proximal end portion coupled to the handle. The proximal end portion of the artificial chorda extends through a lumen defined by the puncture member. The actuator can be actuated at a first time period to move the puncture member distally a preset distance and to move the pusher device distally such that at least a portion of the distal anchor is moved distally relative to the puncture member and disposed distal to the distal end of the puncture member. The actuator can be actuated at a second time period after the first time period to move the distal anchor from its delivery configuration to a deployed configuration.

In some embodiments, a method includes inserting a distal end portion of a delivery device through an apex region of a heart, through a ventricle of the heart and to a proximal side of a valve leaflet. The delivery device has a distal anchor disposed in a delivery configuration at a distal end portion of the delivery device. A distal end of the delivery device is positioned in contact with the proximal side of the leaflet of the valve. The delivery device is actuated during a first time period to move the puncture member distally through the leaflet a preset distance outside the distal end of the delivery device and on a distal side of the leaflet. The puncture member forms, creates, or otherwise defines an opening in the leaflet as the puncture member is moved through the leaflet. The distal anchor is disposed at a distal end portion of an artificial chorda that extends through a lumen of the puncture member and has a proximal end portion coupled to the actuator. Actuating the delivery device during the first time period moves the distal anchor distally relative to the puncture member, through the opening in the leaflet such that at least a portion of the distal anchor is disposed distal to the distal end of the puncture member. The delivery device is actuated during a second time period after the first time period to move the proximal end portion of the artificial chorda proximally causing the distal anchor to move to a deployed configuration.

As illustrated inFIG. 1, thehuman heart10 has four chambers, which include two upper chambers denoted asatria12,16 and two lower chambers denoted asventricles14,18. A septum20 (see, e.g.,FIG. 3) divides theheart10 and separates theleft atrium12 andleft ventricle14 from theright atrium16 andright ventricle18. The heart further contains fourvalves22,23,26, and27. The valves function to maintain the pressure and unidirectional flow of blood through the body and to prevent blood from leaking back into a chamber from which it has been pumped.

Two valves separate theatria12,16 from theventricles14,18, denoted as atrioventricular valves. Themitral valve22, also known as the left atrioventricular valve, controls the passage of oxygenated blood from theleft atrium12 to theleft ventricle14. A second valve, theaortic valve23, separates theleft ventricle14 from the aortic artery (aorta)29, which delivers oxygenated blood via the circulation to the entire body. Theaortic valve23 andmitral valve22 are part of the “left” heart, which controls the flow of oxygen-rich blood from the lungs to the body. The right atrioventricular valve, thetricuspid valve24, controls passage of deoxygenated blood into theright ventricle18. A fourth valve, thepulmonary valve27, separates theright ventricle18 from thepulmonary artery25. Theright ventricle18 pumps deoxygenated blood through thepulmonary artery25 to the lungs wherein the blood is oxygenated and then delivered to theleft atrium12 via the pulmonary vein. Accordingly, thetricuspid valve24 andpulmonic valve27 are part of the “right” heart, which control the flow of oxygen-depleted blood from the body to the lungs.

Both the left andright ventricles14,18 constitute “pumping” chambers. Theaortic valve23 andpulmonic valve27 lie between a pumping chamber (ventricle) and a major artery and control the flow of blood out of the ventricles and into the circulation. Theaortic valve23 andpulmonic valve27 have three cusps, or leaflets, that open and close and thereby function to prevent blood from leaking back into the ventricles after being ejected into the lungs oraorta29 for circulation.

Both the left andright atria12,16 are “receiving” chambers. Themitral valve22 andtricuspid valve24, therefore, lie between a receiving chamber (atrium) and a ventricle so as to control the flow of blood from the atria to the ventricles and prevent blood from leaking back into the atrium during ejection from the ventricle. Both themitral valve22 andtricuspid valve24 include two or more cusps, or leaflets (not shown inFIG. 1), that are encircled by a variably dense fibrous ring of tissues known as the annulus (not shown inFIG. 1). The valves are anchored to the walls of the ventricles by chordae tendineae (chordae; singular “chorda”)17. Thechordae tendineae17 are cord-like tendons that connect thepapillary muscles19 to the leaflets (not shown inFIG. 1) of themitral valve22 andtricuspid valve24 of theheart10. Thepapillary muscles19 are located at the base of thechordae17 and are within the walls of the ventricles. Thepapillary muscles19 do not open or close the valves of the heart, which close passively in response to pressure gradients; rather, thepapillary muscles19 brace the valves against the high pressure needed to circulate the blood throughout the body. Together, thepapillary muscles19 and thechordae tendineae17 are known as the subvalvular apparatus. The function of the subvalvular apparatus is to keep the valves from prolapsing into the atria when they close.

Themitral valve22 is illustrated inFIG. 2A. Themitral valve22 includes two leaflets, theanterior leaflet52 and theposterior leaflet54, and a diaphanous incomplete ring around the valve, called theannulus53. Themitral valve22 has twopapillary muscles19, the anteromedial and the posterolateral papillary muscles (see, e.g.,FIG. 1), which attach theleaflets52,54 to the walls of theleft ventricle14 via the chordae tendineae17 (see, e.g.,FIG. 1).

FIG. 2B illustrates a prolapsedmitral valve22. As can be seen with reference toFIG. 2B-2D, prolapse occurs when a prolapsed segment of aleaflet52,54 of themitral valve22 is displaced above the plane of the mitral annulus into the left atrium12 (seeFIGS. 2C and 2D) preventing the leaflets from properly sealing together to form the natural plane or line of coaptation between the valve leaflets during systole. Because one or more of theleaflets52,54 malfunction, themitral valve22 does not close properly, and, therefore, theleaflets52,54 fail to coapt. This failure to coapt causes agap55 between theleaflets52,54 that allows blood to flow back into the left atrium, during systole, while it is being ejected by the left ventricle. As set forth above, there are several different ways a leaflet may malfunction, which can thereby lead to regurgitation.

Mitral valve regurgitation increases the workload on the heart and may lead to very serious conditions if left un-treated, such as decreased ventricular function, pulmonary hypertension, congestive heart failure, permanent heart damage, cardiac arrest, and ultimately death. Since the left heart is primarily responsible for circulating the flow of blood throughout the body, malfunction of themitral valve22 is particularly problematic and often life threatening.

As described in detail in PCT International Application No. PCT/US2012/043761 (published as WO 2013/003228 A1) (referred to herein as “the '761 PCT Application”), the entire disclosure of which is incorporated herein by reference, methods and devices are provided for performing non-invasive procedures to repair a cardiac valve, such as a mitral valve. Such procedures include procedures to repair regurgitation that occurs when the leaflets of the mitral valve do not coapt at peak contraction pressures, resulting in an undesired back flow of blood from the ventricle into the atrium. As described in the '761 PCT Application, after the malfunctioning cardiac valve has been assessed and the source of the malfunction verified, a corrective procedure can be performed. Various procedures can be performed in accordance with the methods described therein to effectuate a cardiac valve repair, which will depend on the specific abnormality and the tissues involved.

In one example method, the heart may be accessed through one or more openings made by a small incision(s) in a portion of the body proximal to the thoracic cavity, for example, between one or more of the ribs of the rib cage of a patient, proximate to the xyphoid appendage, or via the abdomen and diaphragm. Access to the thoracic cavity may be sought so as to allow the insertion and use of one or more thorascopic instruments, while access to the abdomen may be sought so as to allow the insertion and use of one or more laparoscopic instruments. Insertion of one or more visualizing instruments may then be followed by transdiaphragmatic access to the heart. Additionally, access to the heart may be gained by direct puncture (i.e., via an appropriately sized needle, for instance an 18-gauge needle) of the heart from the xyphoid region. Accordingly, the one or more incisions should be made in such a manner as to provide an appropriate surgical field and access site to the heart. Access may also be achieved using percutaneous methods. See for instance, “Full-Spectrum Cardiac Surgery Through a Minimal Incision Mini-Sternotomy (Lower Half) Technique,” Doty et al.Annals of Thoracic Surgery1998; 65(2): 573-7 and “Transxiphoid Approach Without Median Stermotomy for the Repair of Atrial Septal Defects,” Barbero-Marcial et al.Annals of Thoracic Surgery1998; 65(3): 771-4, which are incorporated in their entirety herein by reference.

After prepping and placing the subject under anesthesia, a transesophageal echocardiogram (TEE) (2D or 3D), a transthoracic echocardiogram (TTE), intracardiac echo (ICE), or cardio-optic direct visualization (e.g., via infrared vision from the tip of a 7.5 F catheter) may be performed to assess the heart and its valves.

After a minimally invasive approach is determined to be advisable, one or more incisions are made proximate to the thoracic cavity so as to provide a surgical field of access. The total number and length of the incisions to be made depend on the number and types of the instruments to be used as well as the procedure(s) to be performed. The incision(s) should be made in such a manner so as to be minimally invasive. As referred to herein, the term “minimally invasive” means in a manner by which an interior organ or tissue may be accessed with as little as possible damage being done to the anatomical structure through which entry is sought. Typically, a minimally invasive procedure is one that involves accessing a body cavity by a small incision of, for example, approximately 5 cm or less made in the skin of the body. The incision may be vertical, horizontal, or slightly curved. If the incision is placed along one or more ribs, it should follow the outline of the rib. The opening should extend deep enough to allow access to the thoracic cavity between the ribs or under the sternum and is preferably set close to the rib cage and/or diaphragm, dependent on the entry point chosen.

One or more other incisions may be made proximate to the thoracic cavity to accommodate insertion of a surgical scope so as to allow ready access to and visualization of the heart. The surgical scope may be any type of endoscope, but is typically a thorascope or laparoscope, dependent upon the type of access and scope to be used. At this point, the practitioner can confirm that access of one or more cardiac valves through the apex region of the heart is appropriate for the particular procedure to be performed.

Once a suitable entry point has been established, the surgeon can use one or more sutures to make a series of stitches in one or more concentric circles in the myocardium at the desired location to create a “pursestring” closure. The Seldinger technique can be used to access the left ventricle in the area surrounded by the pursestring suture by puncturing the myocardium with a small sharp hollow needle (a “trocar”) with a guidewire in the lumen of the trocar. Once the ventricle has been accessed, the guidewire can be advanced, and the trocar removed. A valved-introducer with dilator extending through the lumen of the valved-introducer can be advanced over the guidewire to gain access to the left ventricle. The guidewire and dilator can be removed and the valved-introducer will maintain hemostasis, with or without a suitable delivery device inserted therein, throughout the procedure. Alternatively, the surgeon can make a small incision in the myocardium and insert the valved-introducer into the heart via the incision. Once the valved-introducer is properly placed the pursestring suture is tightened to reduce bleeding around the shaft of the valved-introducer.

A suitable device such as a delivery device described herein, may be advanced into the body and through the valved-introducer in a manner so as to access the left ventricle. The advancement of the device may be performed in conjunction with sonography or direct visualization (e.g., direct transblood visualization). For example, the delivery device may be advanced in conjunction with TEE guidance or ICE so as to facilitate and direct the movement and proper positioning of the device for contacting the appropriate apical region of the heart. Typical procedures for use of echo guidance are set forth in Suematsu, Y., J.Thorac. Cardiouasc. Surg.2005; 130:1348-1356, herein incorporated by reference in its entirety.

As shown inFIG. 3, one or more chambers, i.e., theleft atrium12,left ventricle14,right atrium16, orright ventricle18 in theheart10 may be accessed in accordance with the methods disclosed herein. Access into achamber12,14,16,18 in theheart10 may be made at any suitable site of entry but is preferably made in the apex region of the heart, for example, slightly above the apex26 at the level of the papillary muscles19 (see alsoFIG. 2C). Typically, access into theleft ventricle14, for instance, to perform a mitral valve repair, is gained through the process described above performed in the apical region, close to (or slightly skewed toward the left of) themedian axis28 of theheart10. Typically, access into theright ventricle18, for instance, to perform a tricuspid valve repair, is gained through the process described above performed in the apical region, close to or slightly skewed toward the right of themedian axis28 of theheart10. Generally, an apex region of the heart is a bottom region of the heart that is within the left or right ventricular region and is below themitral valve22 andtricuspid valve24 and toward the tip orapex26 of theheart10. More specifically, an “apex region” AR of the heart (seeFIGS. 2C and 3) is within a few centimeters to the right or to the left of theseptum20 of theheart10 at or near the level of thepapillary muscles19. Accordingly, the ventricle can be accessed directly via the apex26, or via an off apex location that is in the apical or apex region AR, but slightly removed from the apex26, such as via a lateral ventricular wall, a region between the apex26 and the base of apapillary muscle19, or even directly at the base of apapillary muscle19 or above. Typically, the incision made to access the appropriate ventricle of the heart is no longer than about, for example, 0.5 cm. Alternatively, access can be obtained using the Seldinger technique described above.

Themitral valve22 andtricuspid valve24 can be divided into three parts—an annulus (see53 inFIGS. 2A and 2B), leaflets (see52,54 inFIGS. 2A and 2B), and a sub-valvular apparatus. The sub-valvular apparatus includes the papillary muscles19 (seeFIG. 1) and the chordae tendineae17 (seeFIG. 1), which can elongate and or rupture. If the valve is functioning properly, when closed, the free margins or edges of the leaflets come together and form a tight junction, the arc of which, in the mitral valve, is known as the line, plane or area of coaptation (see, e.g., encircled area labeled AC inFIG. 27). Normal mitral and tricuspid valves open when the ventricles relax allowing blood from the atrium to fill the decompressed ventricle. When the ventricle contracts, chordae tendineae properly position the valve leaflets such that the increase in pressure within the ventricle causes the valve to close, thereby preventing blood from leaking into the atrium and assuring that all of the blood leaving the ventricle is ejected through the aortic valve (not shown) and pulmonic valve (not shown) into the arteries of the body. Accordingly, proper function of the valves depends on a complex interplay between the annulus, leaflets, and subvalvular apparatus. Lesions in any of these components can cause the valve to dysfunction and thereby lead to valve regurgitation. As set forth above, regurgitation occurs when the leaflets do not coapt properly at peak contraction pressures. As a result, an undesired back flow of blood from the ventricle into the atrium occurs.

Although the procedures described herein are with reference to repairing a cardiac mitral valve or tricuspid valve by the implantation of one or more artificial chordae, the methods presented are readily adaptable for various types of leaflet and annular repair procedures. In general, the methods herein will be described with reference to amitral valve22.

Some embodiments described herein refer to a deliver device that includes a needle as a puncture member configured to pierce a cardiac tissue such as a mitral valve leaflet. It should be understood that although such embodiments are described with reference to a needle, in alternative embodiments, a deliver device can include any puncture member suitable to pierce a cardiac tissue and form an opening therethrough. For example, in some embodiments, a puncture member can be a trocar, guidewire, rod, tube, or the like. As a further example, in some embodiments, a puncture member can include an electrosurgical device, i.e., a device with an electrical circuit (or any suitable electrical energy source) operating at a frequency (e.g., a high frequency) configured to cut and/or pierce cardiac tissue.

Some embodiments described herein refer to a delivery device that includes a plunger as an actuator configured to receive a manual force and move within a handle of the delivery device to help deliver and deploy a distal anchor within a heart. For example, in some embodiments, such a delivery device having a manual plunger actuator can be used to deploy a bulky-knot type distal anchor as described herein. It should be understood that although such embodiments are described with reference to a manually actuated plunger, in alternative embodiments, a delivery device can include any suitable actuator, such as, for example, an automatically actuated plunger, and/or a button that when pressed or otherwise activated can actuate an internal mechanism suitable to selectively move components (e.g., a pusher, a puncture member, a suture, etc.) of the delivery device. As a further example, an actuator of a delivery device can include one or more energy storage members configured to selectively move components of the delivery device.

In some embodiments, a method includes the implantation of one or more artificial chordae tendineae into one or more leaflets (e.g.,52,54 inFIGS. 2A and 2B) of a malfunctioningmitral valve22 and/ortricuspid valve24. After an appropriate incision has been made in the apex region of the heart, for example, in the apex26, a delivery device can be introduced into, for example, theleft ventricle14 of the heart and advanced in such a manner so as to contact one or more cardiac tissues (for instance, a leaflet, an annulus, a cord, a papillary muscle, or the like) that are in need of repair. Sonic guidance, for instance, TEE guidance or ICE, may be used to assist in the advancement of the device into the ventricle, the proper positioning of the distal tip of the device on the proximal side of the leaflet and, if necessary, the grasping of the cardiac tissue with the device. Direct trans-blood visualization may also be used.

FIG. 4 is a schematic illustration of a portion of a heart with a delivery device inserted therein, according to an embodiment. Thedelivery device130 can include adistal end portion132 configured to be inserted into a heart H, anelongate portion134 coupled to thedistal end portion132, and aproximal end portion136. Thedistal end portion132 of thedelivery device130 can include a puncture or piercing member (not shown) and an anchor support portion (not shown). Thedistal end portion132 can include other features to enable thedelivery device130 to perform various functions, such as, for example, grasping, suctioning, irrigating, cutting, suturing, or otherwise engaging a cardiac tissue.

Theproximal end portion136 can include, for example, a handle that can be used by the user/operator to manipulate movement of thedelivery device130 and/or to actuate thedelivery device130. Theproximal end portion136 can also include control features and/or components that can be used to actuate various functions of thedelivery device130. Theproximal end portion136 can also include a holding device or member that can be used to hold and control a tether (e.g., suture, cord or wire) extending from a distal anchor (described in more detail below) during deployment of the distal anchor.

Using, for example, ultrasound guidance (real-time transesophageal echocardiography), thedelivery device130 can be inserted through an access port at the apex Ap (or near the apex) of the heart H and guided through the left ventricle LV and into contact with a proximal side of a mitral valve leaflet L1 (or L2), shown inFIGS. 4 and 5, at a location where the user/operator has determined that a repair is needed. Typically, this would be a prolapsed segment of the body of the anterior or posterior leaflet, i.e. in a location where the valve has prolapsed as a result of a broken or elongated chorda. Thedistal end portion130 of thedelivery device130 can be used to puncture or form an opening in the valve leaflet L1 and/or the valve leaflet L2. For example, as shown inFIG. 4, the piercing member at adistal tip138 can be used to puncture or pierce through the leaflet L2. This can be done with or without grasping, capturing, or otherwise immobilizing the prolapsed segment of the leaflet.

Thedistal tip138 of thedelivery device130 can be inserted through the puncture site or opening and positioned on a distal side of the leaflet L2 and within the left atrium LA. When thedistal tip138 is in the desired position, thedelivery device130 can be actuated to insert adistal anchor140 or form a distal anchor140 (see,FIG. 5) on the distal side of the leaflet L2 within the left atrium LA of the heart H. In some embodiments, thedistal anchor140 can include a suture or a suture/guide wire combination that can form into a knot upon actuation of thedelivery device130. For example, in some embodiments, thedistal anchor140 includes a large or bulky knot made of ePTFE suture or other appropriate material that is formed by thedelivery device130 and that attains a significant size in the left atrium LA, above the leaflet L2. The knot can be in the form of one or more multi-turn coils of the suture or other material used to form the tether (described in more detail below), which coils can be changed from an elongated configuration to a knot configuration by approximating opposite ends of the coil(s) towards each other to form one or more loops. In some embodiments, thedistal anchor140 includes an anchor member that is deployed into the left atrium LA above the leaflet L2 upon actuation of thedelivery device130.

Thedistal anchor140, whether formed by thedelivery device130 or deployed by thedelivery device130 can be coupled to atether142 extending proximally from thedistal anchor140 and secured to theproximal end portion136 of thedelivery device130. Alternatively, thedistal anchor140 and thetether142 can be all one component (i.e., ePTFE suture) where thedistal anchor140 is formed by altering the shape of thetether142 from a first position to a second position. As described above, theproximal end portion136 of thedelivery device130 can include a holding device (not shown) that can be used to secure and control thetether142 during delivery and deployment of thedistal anchor140.

As shown inFIG. 5, after thedistal anchor140 has been deployed or formed, thedelivery device130 can be withdrawn from the heart H. The length of thetether142 between thedistal anchor140 and the opening in the heart can be adjusted, as discussed above, until the desired length is established (i.e. prolapse of the leaflet is prevented, but the leaflet can still move distally sufficient to coapt with the other leaflet(s)). The proximal end of thetether142 can then be secured to an outer surface of the heart H at, for example, the apex Ap region, with aproximal anchor144. Theproximal anchor144 can be, for example, a pledget, one or more knots, or other suitable anchoring device.

The above procedure can be performed multiple times on the same leaflet, and/or can be performed on the other mitral valve leaflet L1 in the same manner. The result can thus be that two or more anchor-tether apparatuses145 are each anchored on a distal side of a leaflet L1, L2 with adistal anchor140 and secured to the apex Ap region of the heart H with aproximal anchor144 via thetether142. Thus, each anchor-tether apparatus145 can secure the top of the leaflet L1, L2 to the apex Ap region of the heart H, functioning as an artificial chorda or neochord.

FIGS. 6-10 show a schematic illustration of an embodiment of a distal anchor that can be deployed on a distal side of a mitral valve leaflet, and a delivery device for deploying such a distal anchor within the heart of a patient. In this embodiment, a distal anchor240 (see, e.g.,FIGS. 9 and 10) includes a pre-formed knot that can be formed/deployed using adelivery device230. As shown inFIG. 6, thedelivery device230 includes adistal portion232, amedial portion234, and aproximal end portion236. Disposed on thedistal end portion232 is adistal end effector233 that is coupled to a distal end portion of an elongateouter tube231 and can be placed in contact with a proximal side of a mitral valve leaflet L during deployment of thedistal anchor240. Thedistal end effector233 can distribute the force of the elongateouter tube231 over a larger area to prevent/eliminate puncturing of the leaflet with thedelivery device230 during deployment. In some embodiments, theend effector233 can include a balloon. A proximal end portion of theouter tube231 is coupled to ahandle235 at theproximal end portion236. Coupled to or included at least partially within thehandle235 are anelongate pusher237 coupled to apusher hub239, a puncture member241 (e.g., a needle) coupled to a puncture member hub243 (e.g., a needle hub), and asuture catch246. Thepusher237 is movably disposed within a lumen of theouter tube231 and theneedle241 is movably disposed within a lumen of thepusher237. Theneedle241 includes at a distal end a piercing member orportion247 as shown inFIG. 7. In some embodiments, the elongateouter tube231 can provide a relatively stiff structure and can protect thepuncture member241 and/or thepusher237 during delivery and deployment of the distal anchor, and during withdrawal of the delivery device from within the patient. In other embodiments, the delivery device does not include an elongate outer tube or distal end effector. In such embodiments, in some instances, a separate device can be used to provide functionality similar to the functionality provided by the elongateouter tube231 and thedistal end effector233 described above.

A suture242 (also referred to herein as “tether”) is coupled to thesuture catch246 and extends through a lumen of theneedle241 and is formed into a coiled configuration at thedistal end portion232 of thedelivery device230 as shown inFIG. 6. Thesuture catch246 can be configured to releasably hold or secure thesuture242 during delivery of thedistal anchor240 as describe in more detail below. In some embodiments, thesuture catch246 can hold thesuture242 with a friction fit or with a clamping force and can have a lock that can be released after thedistal anchor240 has been deployed/formed. The distal coiled portion of thesuture242 will be formed into thedistal anchor240 upon actuation of thedelivery device230 as described in more detail below. As discussed above fordistal anchor140, the distal anchor240 (e.g., bulky knot) can be in the form of one or more multi-turn coils of thesuture242 that can be changed from an elongated configuration during delivery (see, e.g.,FIGS. 7, 11, and 13A) to a knot configuration (see, e.g.,FIGS. 9, 10, 12 and 13C) by approximating opposite ends of the coil(s) towards each other, to form one or more loops. For example, two strands or lengths of thesuture242 extend from opposite ends of the elongate coiled portion of thesuture242 and extend through thedelivery device230. When the two proximal ends of thesuture242 are pulled proximally, the opposite ends of the coiled portions are pulled towards each other to form the loops.

FIGS. 13A-13C illustrate the sequence described above with respect to thedistal anchor140 and thedistal anchor240 transitioning from an elongated configuration to a knot configuration, however for ease of illustration, a single coil and loop variation is shown and described. As shown inFIG. 13A, thedistal anchor240′ is in a coiled, elongated formation (e.g., a preformed knot) configured for delivery to a heart. To form the knot configuration (as shown inFIG. 13C), a proximal end of thesuture242′ is pulled proximally to deflect the distal end DE of the coil laterally with respect to the proximal end PE of the coil and to draw the proximal end PE of the coil and the distal end DE of the coil towards each other to form a loop L, as illustrated inFIGS. 13B and 13C.

To deliver and form thedistal anchor240 within, for example, a left atrium of the heart to repair a mitral valve, the distal end portion of theneedle241 of thedelivery device230 can be inserted through an apex portion of the heart and into the left ventricle until theend effector233 contacts a proximal side of the mitral valve leaflet L as shown inFIGS. 6-9. With thedelivery device230 positioned against the mitral leaflet L, and with a proximal end portion of the suture232 (i.e., the two proximal end portions of the suture242) secured to thesuture catch246, theneedle241 andneedle hub243, thepusher237 andpusher hub239, and thesuture catch246 are all moved distally (in the direction of arrow A) relative to thehandle235 as shown inFIG. 7, until thepusher237 andpusher hub239 locks into place relative to thehandle235. As these components are collectively moved distally, the piercingportion247 of theneedle241 punctures the leaflet L forming an opening, and is passed through the leaflet L and is disposed on the distal side of the leaflet L. In some embodiments, the distal end of piercingportion247 extends outside of theend effector233 of thedelivery device230 about 1.0 inch. Simultaneously, thepusher237 pushes or moves the distal anchor240 (i.e., the distal coiled portion of the suture232), still in an elongated configuration and surrounding a portion of theneedle241, through the opening in the leaflet L until it is disposed on the distal side of the leaflet L. As shown inFIG. 7, the piercingportion247 of theneedle241 extends beyond thedistal anchor240.

As shown inFIG. 8, theneedle241 andneedle hub243 can then be withdrawn or moved proximally in the direction of arrow B until contact is made between theneedle hub243 and thesuture catch246, leaving thedistal anchor240 in the left atrium on the distal side of the leaflet L. As the needle hub243 (and needle241) continue to be moved proximally in the direction of arrow B, thedistal anchor240 will begin to form a knot because the suture242 (e.g., the two end portions of suture242) is secured to thesuture catch246 such that as thesuture catch246 is moved proximally it pulls thedistal anchor240 approximating opposite ends of the coils towards each other to form one or more loops as show inFIGS. 9 and 10. Further, there is a length ofsuture242 between thesuture catch246 and the proximal end of theneedle241 which allows thesuture242 to slide off theneedle241 before the knot is formed. When theneedle241 is withdrawn, the wraps of thesuture242 stay in the same place, eliminating the extra length ofsuture242 between the distal end of theneedle241 and thesuture catch246. The knot is thus formed on a distal end of thepusher237 and not against the mitral valve leaflets. After thedistal anchor240 has formed a knot (as inFIGS. 9 and 10), the proximal end portions of thesuture242 can be released from thesuture catch246 and thedelivery device230 can be withdrawn proximally in the direction of arrow B, leaving thedistal anchor240 disposed on the distal side of the leaflet L, and two lengths of thesuture242 extending out of the heart. In other words, with thesuture242 released from thesuture catch246, thedelivery device230 can be slid over thesuture242 for removal.

As described above fordistal anchor140 andtether142, the length of thesuture242 between thedistal anchor240 and the opening in the heart can be adjusted, as discussed above, until the desired length is established (i.e. prolapse of the leaflet is prevented, but the leaflet can still move distally sufficient to coapt with the other leaflet(s)). The proximal ends of thesuture242 can then be secured to an outer surface of the heart at, for example, the apex region, with a proximal anchor (not shown). The proximal anchor can be, for example, a pledget, one or more knots, or other suitable anchoring device. As previously described, the above procedure can be performed multiple times on the same leaflet, and/or can be performed on the other mitral valve leaflet in the same manner. The result can thus be that one or more anchor-tether apparatuses (e.g., anchor-tether apparatus145) as described above are each anchored on a distal side of a leaflet with a distal anchor and secured to the apex of the heart with a proximal anchor via thesuture242. Alternatively, if one or more anchor-tether apparatus are attached to both mitral valve leaflets, an anchor-tether apparatus attached to each leaflet can be secured together in the heart by tying them together with knots or by another suitable attachment member (not shown), creating an edge-to-edge repair to decrease the septal-lateral distance of the mitral valve orifice. The two attached anchor-tether apparatus can be left loose or tensioned to create a “facilitated” edge-to-edge repair before being secured to an outer surface of the heart with a proximal anchor.

FIGS. 6-10 illustrate one example method and device for deploying a bulky knot distal anchor. In another embodiment, a bulky knot distal anchor can be deployed/formed using a delivery device that utilizes a short throw deployment sequence configured to insert the distal end portion and piercing member of the needle a shorter distance into the left atrium than as shown and described above for the embodiment ofFIGS. 6-10. In such an embodiment, the distal end portion of the needle is used to puncture the leaflet tissue and form an opening in the leaflet tissue, but does not extend as far into the left atrium. In some embodiments, the needle can be extended outside of the distal end of the delivery device (e.g., beyond the end effector) half the distance than what is shown and described for the embodiment ofFIGS. 6-10. For example, in some embodiments, the needle can be extended outside the delivery device a distance of about 0.2-0.3 inches (e.g., 0.25 inches). In other embodiments, the needle can be extended outside the delivery device a distance of about 0.15-0.4 inches. Similarly, in some embodiments, a needle can be extended through a proximal side of a heart valve leaflet a distance, for example, of about 0.2-0.3 inches or a distance of about 0.15-0.4 inches from the proximal side of the heart valve leaflet. As yet a further example of the short throw deployment sequence, the needle can be moved a distance sufficient to pierce the proximal side of the leaflet and extend a distance of about 0.05-0.25 inches (e.g., 0.1 inch) from and distal to the distal side of the leaflet. The distal coiled portion of the suture is then moved distally over the needle and into the left atrium using a pusher device. By shortening the distance in which the needle is extended outside of the end effector and into the left atrium, the potential for damage to surrounding tissue can be reduced or eliminated. Further, in some cases, such a short throw deployment sequence can help limit or prevent damage to the needle itself. For example, in some cases, if the needle is extended too far distally outside of the outer tube, the needle may bend unwantedly.FIGS. 14A-14E are schematic illustrations of an embodiment of a delivery device for delivering and deploying a distal anchor and configured to provide such a short throw deployment sequence.

As shown inFIGS. 14A-14E, adelivery device330 includes adistal end portion332, aproximal end portion336 and amedial portion334. Thedistal end portion332 can include anend effector333 that can be placed in contact with a leaflet L of a mitral valve as described above. Theend effector333 can be coupled to a distal end portion of an outer tube331 and a proximal end portion of the outer tube331 is coupled to ahandle335 at theproximal end portion336. Theend effector333 can distribute the force of the outer tube331 over a larger area to prevent/eliminate puncturing of the leaflet with thedelivery device330 during deployment. In some embodiments, theend effector333 can include a balloon. Anelongate pusher337 is movably disposed within a lumen of the outer tube331 and is coupled to apusher hub339 that is movably disposed within thehandle335 and releasably coupled to a plunger (not shown). A needle341 (seeFIGS. 14C and 14D) is movably disposed within a lumen of thepusher337 and is coupled to aneedle hub243 that is also coupled to the plunger (not shown). The plunger is used to actuate or move theneedle341 and thepusher337 during deployment of adistal anchor340 and can be movably disposed at least partially within thehandle335 as described in more detail below fordelivery device430. For example, thehandle335 defines a lumen in which the plunger can be moved. During operation, thepusher337 also moves within the lumen of thehandle335 as described in more detail below. Thedelivery device330 can also include a locking lever (not shown) that can be used to prevent the plunger from moving within thehandle335 during storage and prior to performing a procedure to deploy the distal anchor.

A suture catch346 (also referred to as “tether catch”) is also coupled to the plunger at a proximal end of thedelivery device330. Thesuture catch346 can be configured to releasably hold or secure asuture342 extending through thedelivery device330 during delivery of thedistal anchor340 as described above and as described in more detail below with reference todelivery device430. In some embodiments, thesuture catch346 can hold thesuture342 with a friction fit or with a clamping force and can have a suture lock that can be released after thedistal anchor340 has been deployed/formed into a bulky knot.

The suture342 (also referred to herein as “tether”) is formed into an elongated coiled configuration and is disposed within the outer tube331 at thedistal end portion332 of thedelivery device330. As described above forsuture242, two strands of thesuture342 extend from the distal elongated coiled portion of thesuture342, extend through the lumen of theneedle341, through a passageway of the plunger and exit the plunger andneedle341 at a proximal end portion of the plunger. The distal elongated coiled portion of thesuture342 will be formed into the distal anchor340 (e.g., bulky knot) upon actuation of thedelivery device330 as described in more detail below. As discussed above fordistal anchors140 and240, thedistal anchor340 can be in the form of one or more multi-turn coils of thesuture342 that can be changed from the elongated coiled configuration during delivery to a knot configuration by approximating opposite ends of the coils towards each other, to form one or more loops.

To deliver and form thedistal anchor340 within, for example, a left atrium of the heart to repair a mitral valve, the distal end portion of332 of thedelivery device330 can be inserted through an apex portion of the heart and into the left ventricle until theend effector333 contacts a proximal side of the mitral valve leaflet L as shown inFIG. 14A. In this embodiment, with thedelivery device330 positioned against the mitral leaflet L, and with a proximal end portion of the suture342 (e.g., two suture strands of suture342) secured to thesuture catch346, the plunger (not shown) is actuated to move theneedle hub343, theneedle341, thepusher337 andpusher hub339, and the coiled portion of the suture332 (e.g., distal anchor340) distally until the plunger contacts a stop member (not shown) within thehandle335, which limits the travel of the plunger in the distal direction. As the plunger is actuated, a distal piercingportion347 of theneedle341 and in some cases, at least the first wrap of the coiled portion of the suture, punctures the leaflet L and forms an opening in the leaflet L (see e.g.,FIG. 14B). The distance the distal end portion of theneedle341 extends within the left atrium on the distal side of the leaflet L is determined by the amount of travel allowed by the plunger. Thus, in this embodiment, thedelivery device330 is configured to advance the distal end portion of the needle341 a shorter distance, for example, between about 0.2-0.3 inches (e.g., 0.25 inches), or less, distally beyond the distal end of the delivery device330 (e.g., beyond the end effector333), compared to the embodiment ofFIGS. 6-10 in which the needle extends about 1.0 inch. In other embodiments, the needle can be extended outside the delivery device a distance of about 0.15-0.4 inches. When the plunger reaches the stop member, thepusher337 andpusher hub339 are released from the plunger348 and are advanced further distally to a distal position within the handle335 (seeFIG. 14C) where the pusher hub339 (and pusher337) can optionally lock into place. Details of how thepusher337 andpusher hub339 are moved within the lumen of thehandle335 are described below with respect todelivery device430.

As thepusher337 is moved distally, a distal end of thepusher337 moves or pushes the distal coiled portion of the suture342 (i.e., distal anchor340) over the distal end of theneedle341 and further within the left atrium of the heart on a distal side of the mitral leaflet (seeFIG. 14C). In other words, the distal end of thepusher337 and the distal coiled portion of thesuture342 extends beyond the distal end of theneedle341. For example, in some embodiments, at least half a length of the distal coiled portion of thesuture342 extends beyond the distal end of theneedle341. In some embodiments, at least three quarters of the length of the distal coiled portion of thesuture342 extends beyond the distal end of theneedle341. In other embodiments, the entire length of the distal coiled portion of thesuture342 extends beyond the distal end of theneedle341. To allow the distal coiled portion of the suture342 (i.e., distal anchor340) to slide relative to the plunger, when thesuture342 is loaded within thedelivery device330, there is slack in thesuture342 between the distal coiled portion of thesuture342 and the suture lock within thesuture catch346.

After the distal coiled portion of thesuture342 is moved to the distal side of the leaflet L, the plunger is then released such that the plunger moves proximally, which moves or pushes theneedle341 andsuture catch346 proximally, pulling the suture342 (e.g., suture strands extending from the coiled portion of the suture) through thepusher337 to form the bulky knot configuration (as shown inFIG. 14D) of thedistal anchor340 by approximating opposite ends of the coils of the elongated coil portion of thesuture342 towards each other, to form one or more loops. As shown inFIG. 14D, by pulling on the proximal ends of thesuture342, the coils are pulled against the distal end of thepusher337 to form the knot. After thedistal anchor340 has formed a knot, the proximal end portions of thesuture342 can be released from thesuture catch346 and thedelivery device330 can be withdrawn proximally, leaving thedistal anchor340 disposed on the distal side of the leaflet L (as shown inFIG. 14E), and two lengths or strands of thesuture332 extending out of the heart. In other words, with thesuture342 released from thesuture catch346, thedelivery device330 can be slid over thesuture342 for removal.

As described above for previous embodiments, the lengths or strands of thesuture342 between thedistal anchor340 and the opening in the heart can be adjusted until the desired length is established. The proximal ends of thesuture342 can then be secured to an outer surface of the heart at, for example, the apex region, with a proximal anchor (not shown). The proximal anchor can be, for example, a pledget, one or more knots, or other suitable anchoring device. As previously described, the above procedure can be performed multiple times on the same leaflet, and/or can be performed on the other mitral valve leaflet in the same manner. The result can thus be that one or more anchor-tether apparatuses (e.g., anchor-tether apparatus145) as described above are each anchored on a distal side of a leaflet with a distal anchor and secured to the apex of the heart with a proximal anchor via thetether342. Alternatively, if one or more anchor-tether apparatus are attached to both mitral valve leaflets an anchor-tether apparatus attached to each leaflet can be secured together in the heart by tying them together with knots or by another suitable attachment member (not shown), creating an edge-to-edge repair to decrease the septal-lateral distance of the mitral valve orifice. The two attached anchor-tether apparatus can be left loose or tensioned to create a “facilitated” edge-to-edge repair before being secured to an outer surface of the heart with a proximal anchor.

FIGS. 15A-22C and 23-27 illustrate another embodiment of a delivery device that can be used to deliver and form a bulky knot distal anchor to be disposed on a distal side of a mitral valve leaflet using a short throw deployment sequence. As shown in cross-section inFIGS. 15A and 15B, adelivery device430 includes adistal end portion432, aproximal end portion436 and amedial portion434. Thedistal end portion432 can include an end effector433 (best shown inFIG. 15C) that can be placed in contact with a leaflet of a mitral valve as described above. Theend effector433 can be coupled to a distal end portion of an outer tube431 (also shown inFIG. 15C) and a proximal end portion of theouter tube431 is coupled to ahandle435 at theproximal end portion436. Anelongate pusher437 is movably disposed within a lumen of the outer tube431 (see e.g.,FIG. 15C) and is coupled to apusher hub439 that is movably disposed within thehandle435 and releasably coupled to aplunger448. Aneedle441 is movably disposed within a lumen of the pusher437 (see e.g.,FIG. 17B) and is coupled to aneedle hub443 that is also coupled to theplunger448. Theplunger448 is used to actuate or move theneedle441 and thepusher437 during deployment of a distal anchor440 (see e.g.,FIGS. 19B and 20B) and is movably disposed at least partially within thehandle435. For example, thehandle435 defines a lumen in which theplunger448 can be moved. During operation, thepusher437 also moves within the lumen of thehandle435 as described in more detail below. Thedelivery device430 also includes a lockinglever449 that can be used to prevent theplunger448 from moving within thehandle435 during storage and prior to performing a procedure to deploy the distal anchor.

A suture catch446 (also referred to as “tether catch”) is also coupled to theplunger448 at a proximal end of the delivery device430 (best shown inFIG. 15D). Thesuture catch446 can be configured to releasably hold or secure asuture442 extending through thedelivery device430 during delivery of the distal anchor as described above and as described in more detail below. In some embodiments, thesuture catch446 can hold thesuture442 with a friction fit or with a clamping force and can have a lock that can be released after thedistal anchor440 has been deployed/formed into a bulky knot. Thesuture catch446 includes anarm480 and contact members481 (e.g., silicone O-rings) coupled to the arm480 (see e.g.,FIG. 12D). Thearm480 can be moved from a closed position (as shown inFIGS. 15A, 15B, 16, 17A, 18A and 19A) in which thecontact members481 engage thesuture strands442 within aslot483 in theplunger448, to an open position (as shown inFIGS. 15D and 20A) thereby allowing the proximal end portions of thesuture442 to be released from thesuture catch446. Thedelivery device430 can then be withdrawn proximally, leaving thedistal anchor440 disposed on the distal side of the leaflet L, and the two lengths of thesuture442 extending out of the heart, as described with respect to previous embodiments. When in the closed position, thearm480 and thecontact members481 pinch or otherwise secure thesuture442 to prevent or otherwise limit thesuture442 from moving relative to thedevice430. When in the open position (e.g., after delivery of thedistal anchor440 and during removal of thedevice430 from the heart), thearm480 and thecontact members481 allow movement of thesuture442 relative to thedevice430 such that thedevice430 can be separated from thesuture442, as described in more detail below.

A distal end portion of the suture442 (also referred to herein as “tether”) is formed into an elongated coiled configuration and is disposed within theouter tube431 at thedistal end portion432 of thedelivery device430. For example, the coils of thesuture442 can be provided or shipped disposed around theneedle441 with the proximal most coil abutting against thesuture442. As described above for thesuture242 and thesuture342, two strands of thesuture442 extend from the distal elongated coiled portion of thesuture442, extend through the lumen of theneedle441, through a passageway of theplunger448 and exit theplunger448 at a proximal end portion of the plunger448 (see e.g.,FIG. 15D). The distal elongated coiled portion of thesuture442 will be formed into the distal anchor440 (e.g., bulky knot) upon actuation of thedelivery device430 as described in more detail below. As discussed above for thedistal anchors140,240 and340, the distal anchor440 (e.g., bulky knot) can be in the form of one or more multi-turn coils of thesuture442 that can be changed from the elongated coiled configuration during delivery to a knot configuration by approximating opposite ends of the coils towards each other, to form one or more loops.

As shown in detail inFIGS. 22A-22C, thedelivery device430 also includes afluid transfer system460. Thefluid transfer system460 is configured to facilitate flushing of a portion of thedelivery device430 and/or to facilitate the removal of undesirable fluids during the procedure. In some instances, for example, thefluid transfer system460 be used to flush air out of the delivery device430 (e.g., air located between thepusher437 and the outer tube431). As another example, thefluid transfer system460 can be used to limit or prevent blood from undesirably flowing from a patient into thedelivery device430 during a procedure. Thefluid transfer system460 includes afluid pathway461 and aconnection port462 disposed external to thehandle435. As shown best in cross-sectional view inFIG. 22C, thefluid pathway461 is in fluid communication with theconnection port462 and a volume defined between the lumen of theouter tube431 and an outer surface of thepusher437. Further, as shown best inFIG. 22C, thefluid transfer system460 includes a fluid sealing member465 (e.g., an O-ring) disposed about thepusher437 and configured to fluidically isolate thefluid pathway461 from a volume within thehandle435 proximal to thefluid transfer system460. Thefluid transfer system460 also includes connection port sealing member463 (e.g., a cap, a plug, or the like) configured to be coupled to theconnection port462 to fluidically isolate thefluid pathway461 from a volume external to thefluid transfer system460 and/or thedelivery device430. Optionally, the connectionport sealing member463 can be retained and/or stored proximate to theconnection port462 via a leash member464 (as shown inFIG. 22A).

To prepare thedelivery device430 for delivering and forming adistal anchor440 within, for example, a left atrium of the heart to repair a mitral valve, the lockinglever449 is released from its locked or engaged position (e.g., its position during storage of the delivery device430) in which theplunger448 is prevented from moving (e.g., proximally and distally) within thehandle435 to its unlocked or disengaged position in which theplunger448 can be moved within the handle, as described in further detail below.

To deliver and form thedistal anchor440 within, for example, a left atrium of the heart to repair a mitral valve, the distal end portion of432 of thedelivery device430 can be inserted through an apex portion of the heart and into the left ventricle until theend effector433 contacts a proximal side of the mitral valve leaflet L as shown in progression inFIGS. 23 and 24. With thedelivery device430 positioned against the mitral leaflet L (see e.g.,FIG. 24), and with a proximal end portion of the suture442 (e.g., two suture strands of the suture442) secured to thesuture catch446, theplunger448 is actuated to move theneedle hub443, theneedle441, thepusher437 andpusher hub439, and the coiled portion of the suture432 (e.g., the distal anchor440) distally until theplunger448 contacts astop member421 within the handle435 (see e.g.,FIG. 18A), which limits the travel of theplunger448 in the distal direction. As theplunger448 is actuated, a distal piercing portion447 of theneedle441 punctures the leaflet L and forms an opening in the leaflet L (see e.g.,FIG. 17B). Because theneedle441 is coupled to theplunger448 and moves with theplunger448, the distance the distal end portion of theneedle441 extends within the left atrium on the distal side of the leaflet L (see e.g.,FIG. 17B) is determined by the amount of travel allowed by theplunger448. Thus, in this embodiment, thedelivery device430 is configured to advance the distal end portion of the needle441 a shorter distance, for example, between about 0.2-0.3 inches (e.g., 0.25 inches), or less, distally beyond the distal end of the delivery device430 (e.g., beyond the end effector), compared to the embodiment ofFIGS. 6-10 in which the needle extends about 1.0 inch. In other embodiments, the needle can be extended outside the delivery device a distance of about 0.15-0.4 inches. For example, in some embodiments, the needle extends until the distal tip of theneedle441 and a first wrap or two of the coiledsuture442 extend through the leaflet. When theplunger448 reaches the stop member, thepusher437 andpusher hub439 are released from theplunger448 and are advanced further distally to a distal position within thehandle435, as shown in progression inFIGS. 17A and 18A. Details of how thepusher437 andpusher hub439 are moved within the lumen of thehandle435 and released from theplunger448 are described below with respect toFIGS. 18A-21.

As shown inFIGS. 17A and 18A, thepusher hub439 is configured to complimentarily mate with anopening492 defined by and located at a distal end portion of theplunger448. In use, prior to deployment, a proximal end portion of thepusher hub439 is disposed within theopening492 defined by the plunger448 (see, e.g.,FIGS. 16 and 17A). In this position, a pair oftabs485 of aspring member486 coupled to thepusher hub439 are disposed withinslots487 defined by theplunger448. For example, thespring member486 can have a biased configuration in which thetabs485 are disposed in an open position, and when thepusher hub439 is coupled to theplunger448 thetabs485 are compressed by the inner walls of thehandle435, which define a first portion FP of a passageway within thehandle435. As thepusher hub439 is moved distally, thespring member486 will slide into a second portion SP of the passageway of thehandle435 which has a larger size, allowing thetabs485 to move to their biased open configuration and disengaging thetabs485 from theslots487 of the plunger448 (see, e.g., the progression inFIGS. 17A and 18A).

When theplunger448 is actuated (i.e., moved distally within the handle435), thepusher hub439 will move distally with theplunger448 until theplunger448 reaches the stop member421 (see e.g.,FIG. 18A), at which point thepusher hub439 is moved into the second portion SP of the passageway of thehandle435 as described above, allowing thetabs485 on thespring member486 to disengage or release thepusher hub439 from theplunger448. Upon release from theplunger448, thepusher437 and thepusher hub439 are advanced further distally to a distal position within thehandle435 as shown inFIG. 18A, in response to a force provided by a biasing member490 (e.g., a compression spring) disposed within a lumen of theplunger448. The biasingmember490 is coupled to and disposed between thepusher hub439 and theneedle hub443, as shown inFIG. 21. In this manner, with use of the biasingmember490, a desirable and repeatable force can be applied to thepusher437 and thepusher hub439, resulting in a desirable and repeatable delivery of thedistal anchor440.

Prior to disengagement of thepusher437 and thepusher hub439 from the plunger448 (e.g., prior to use of thedelivery device430 or during use as the distal piercing portion447 of theneedle441 punctures the leaflet L and forms an opening in the leaflet L), the biasingmember490 is in a compressed configuration (not shown) and thepusher437 and thepusher hub439 are in their ready state (see e.g.,FIGS. 16 and 17A), in which a portion of thepusher hub439 is disposed within theopening492 of theplunger448 as described above. To releasably retain the biasingmember490 in the compressed configuration and thepusher437 andpusher hub439 in their ready state, the pair oftabs485 of thespring member486 are disposed within theslots487 of theplunger448 and theplunger448 is disposed in the first portion of the passageway within thehandle435.

As shown inFIG. 21, aguide member455 is disposed within a lumen defined by the biasingmember490 and coupled to thepusher hub439. During distal advancement of thepusher437 and thepusher hub439 within thehandle435, and transition of the biasingmember490 between its unbiased compressed configuration and is biased uncompressed configuration, theguide member455 can facilitate desirable alignment within the handle435 (e.g., alignment within thehandle435 of thepusher437, thepusher hub439, and the plunger448). In addition, theguide member455 can provide structural support to the biasing member490 (e.g., during transition of the biasingmember490 between its biased and unbiased configurations).

Although the lumen of thehandle435 is shown in this embodiment as being rectangular, in some embodiments, the lumen of the handle can have any suitable shape (e.g., a circular or semi-circular shape). In such embodiments, the components that cooperatively function within the handle435 (e.g., thepusher437, thepusher hub439, the plunger448), as described above with respect thedelivery device430, can be suitably sized and/or shaped to cooperatively function with any shape and/or size selected for a particular handle and lumen defined therein.

In use, as theplunger448 is actuated to move thepusher437 and thepusher hub439 distally within thehandle435, theplunger448 will reach thestop member421 at which point in time thespring member486 will slide into the second portion SP of the passageway of thehandle435 which has the larger size, allowing thetabs485 to move to their biased open configuration and disengaging thetabs485 from theslots487 of theplunger448. In this manner, the biasingmember490 will be released from its compressed configuration and transition towards a biased uncompressed configuration thereby resulting in travel of thepusher437 and thepusher hub439 distally within thehandle435. As thepusher437 is moved distally, a distal end of thepusher437 moves or pushes the distal coiled portion of the suture442 (i.e., distal anchor440) over the distal end of theneedle441 and further within the left atrium of the heart on a distal side of the mitral leaflet (see, e.g.,FIGS. 18A, 18B and 25), such that the coiled portion of the suture extends distally beyond a distal end of theneedle441. For example, in some embodiments, at least half a length of the distal coiled portion of thesuture442 extends beyond the distal end of theneedle441. In some embodiments, at least three quarters of the length of the distal coiled portion of thesuture442 extends beyond the distal end of theneedle441. In other embodiments, the entire coiled portion of thesuture442 extends beyond the distal end of theneedle441. To allow the distal coiled portion of the suture442 (i.e., distal anchor440) to slide relative to theplunger448, when thesuture442 is loaded within thedelivery device430, there is slack SL (a portion of which is shown inFIG. 15D) in thesuture442 between the distal coiled portion of thesuture442 and the suture lock within thesuture catch446.

After the distal coiled portion of thesuture442 is moved to the distal side of the leaflet L, theplunger448 is released to allow theplunger448 to move proximally, which moves or pushes theneedle441 andsuture catch446 proximally, as shown inFIG. 19A. For example, in some embodiments, theplunger448 can be actuated by the user manually pushing the plunger distally within thehandle435 with for example a thumb or finger. To release theplunger448, the user can release his thumb which allows theplunger448 to be moved back proximally. For example, in some embodiments, when the user releases his thumb from theplunger448, a biasing member (e.g., a spring) (not shown) can push theplunger448 back in the proximal direction. When thesuture catch446 is moved proximally, this in turn pulls the suture442 (e.g., suture strands extending from the coiled portion of the suture) proximally to form the bulky knot configuration of thedistal anchor440 against the distal end of the pusher437 (see e.g.,FIGS. 18B, 19B, 25 and 26). For example, as described above, the bulky knot is formed by approximating opposite ends of the coils of the elongated coil portion of thesuture442 towards each other, to form one or more loops, as shown inFIG. 16B. After thedistal anchor440 has formed a knot, the proximal end portions of thesuture442 can be released from thesuture catch446. Thedelivery device430 can then be withdrawn proximally, leaving thedistal anchor440 disposed on the distal side of the leaflet L, as shown inFIGS. 20A and 20B, and two lengths or strands of thesuture432 extending from the proximal side of the leaflet L (see e.g.,FIG. 27) and out of the heart. In other words, with thesuture442 released from thesuture catch446 thedelivery device430 can be slid over thesuture442 for removal.

As described above for previous embodiments, the lengths or strands of thesuture442 between thedistal anchor440 and the opening in the heart can be adjusted until the desired length is established. The proximal ends of thesuture442 can then be secured to an outer surface of the heart at, for example, the apex, with a proximal anchor (not shown). The proximal anchor can be, for example, a pledget, one or more knots, or other suitable anchoring device. As previously described, the above procedure can be performed multiple times on the same leaflet, and/or can be performed on the other mitral valve leaflet in the same manner. The result can thus be that one or more anchor-tether apparatuses (e.g., anchor-tether apparatus145) as described above are each anchored on a distal side of a leaflet with a distal anchor and secured to the apex of the heart with a proximal anchor via thetether442. Alternatively, if one or more anchor-tether apparatus are attached to both mitral valve leaflets, an anchor-tether apparatus attached to each leaflet can be secured together in the heart by tying them together with knots or by another suitable attachment member, creating an edge-to-edge repair to decrease the septal-lateral distance of the mitral valve orifice. The two attached anchor-tether apparatus can be left loose or tensioned to create a “facilitated” edge-to-edge repair before being secured to an outer surface of the heart with a proximal anchor. As shown inFIG. 27, with the anchor-tether apparatus secured to the mitral valve leaflet L, when closed, the free margins or edges of the leaflets come together and form a tight junction, the arc of which is known as the line, plane or area of coaptation AC as previously described.

FIGS. 14A-14E described above illustrate one example method and device for deploying a bulky knot distal anchor using a delivery device that utilizes a short throw deployment sequence configured to insert the distal end portion and piercing member of the needle a shorter distance into the left atrium than as shown and described above for the embodiment ofFIGS. 6-10. As shown and described with respect toFIGS. 14A-14E, the distal end portion of the needle is used to puncture the leaflet tissue and form an opening in the leaflet tissue, but does not extend as far into the left atrium. In another embodiment, a bulky knot distal anchor can be deployed/formed using a delivery device that utilizes a full forward short throw deployment sequence. The full forward short throw deployment sequence is similar to the short throw deployment sequence ofFIGS. 14A-14E, but causes the bulky knot distal anchor to be deployed/formed by moving the pusher distally relative to the needle rather than pulling on the proximal ends of the suture to pull the coils against the distal end of the pusher.FIGS. 28A-28E are schematic illustrations of an embodiment of a delivery device for delivering and deploying a distal anchor and configured to provide such a full forward short throw deployment sequence.

As shown inFIGS. 28A-28E, adelivery device530 includes adistal end portion532, aproximal end portion536 and amedial portion534. Thedistal end portion532 includes anend effector533 that can be placed in contact with a leaflet L of a mitral valve as described above with respect toFIGS. 14A-14E. Theend effector533 is coupled to a distal end portion of anouter tube531 and a proximal end portion of theouter tube531 is coupled to ahandle535 at theproximal end portion536 of thedelivery device530. Theend effector533 can distribute the force of theouter tube531 over a larger area to prevent/eliminate puncturing of the leaflet with thedelivery device530 during deployment. In some embodiments, theend effector533 can include a balloon (not shown). Anelongate pusher537 is movably disposed within a lumen of theouter tube531 and is coupled to apusher hub539 that is movably disposed within thehandle535 and releasably coupled to a plunger (not shown). For example, the plunger can be constructed the same as or similar to theplunger448 described above and function in a similar manner. A needle541 (seeFIGS. 28C-28E) is movably disposed within a lumen of thepusher537 and is coupled to aneedle hub543 that is also releasably coupled to the plunger (not shown). The plunger is used to actuate or move theneedle541 and thepusher537 during deployment of adistal anchor540 and can be movably disposed at least partially within thehandle535. For example, thehandle535 defines a lumen in which the plunger can be moved. During operation, thepusher537 also moves within the lumen of thehandle535 as described in more detail below. Thedelivery device530 can also include a locking lever (not shown) that can be used to prevent the plunger from moving within thehandle535 during storage and prior to performing a procedure to deploy the distal anchor. For example, the locking lever can be similar to or the same as the lockinglever449 described above.

A suture catch546 (also referred to as “tether catch”) can be coupled to the plunger at a proximal end of thedelivery device530. Thesuture catch546 is configured to releasably hold or secure asuture542 extending through thedelivery device530 during delivery of thedistal anchor540 as described above for previous embodiments. In some embodiments, thesuture catch546 can hold thesuture542 with a friction fit or with a clamping force and can have a lock that can be released after thedistal anchor540 has been deployed/formed into a bulky knot.

As described above for previous embodiments, the suture542 (also referred to herein as “tether”) can be formed into an elongated coiled configuration and is disposed within theouter tube531 at thedistal end portion532 of thedelivery device530. As described above, for example, forsuture242, two strands of thesuture542 can extend from the distal elongated coiled portion of thesuture542, extend through the lumen of theneedle541, through a passageway of the plunger and exit the plunger andneedle541 at a proximal end portion of the plunger. The distal elongated coiled portion of thesuture542 will be formed into the distal anchor540 (e.g., bulky knot) upon actuation of thedelivery device530 as described in more detail below. As discussed above for previous embodiments, thedistal anchor540 can be in the form of one or more multi-turn coils of thesuture542 that can be changed from the elongated coiled configuration during delivery to a knot configuration by approximating opposite ends of the coils towards each other, to form one or more loops.

To deliver and form thedistal anchor540 within, for example, a left atrium of the heart to repair a mitral valve, the distal end portion of532 of thedelivery device530 can be inserted through an apex portion or region of the heart and into the left ventricle until theend effector533 contacts a proximal side of the mitral valve leaflet L as shown inFIG. 28A. In this embodiment, with thedelivery device530 positioned against only the ventricular side of the mitral leaflet L, without contacting the atrial side of that leaflet, and with a proximal end portion of the suture542 (e.g., two suture strands of suture542) secured to thesuture catch546, the plunger (not shown) can be actuated (e.g., moved or pushed in a distal direction relative to the handle535). The actuation of the plunger moves theneedle hub543, theneedle541, thepusher537 andpusher hub539, thesuture catch546, and the coiled portion of the suture542 (e.g., distal anchor540) distally until the needle hub543 (and needle541) and thesuture catch546 reach a preset location within the handle where theneedle hub543,needle541, andsuture catch546 are disengaged from the plunger and their travel in the distal direction is stopped. Thepusher537, thepusher hub539, and the coiled portion of thesuture542 continue to be moved distally by the plunger.

In some embodiments, for example, a delivery device can include a release mechanism configured to disengage the needle hub, the needle, and the suture catch from the plunger such that the plunger can continue to advance distally and move the pusher, the pusher hub, and the coiled portion of the suture distally. In some embodiments, the release mechanism can be configured for automatic disengagement, while in other embodiments, the mechanism can be configured to be actuated by the operator. In some embodiments, the delivery device can also include one or more stop members within the handle that can engage or contact the needle hub (and suture catch) to limit or stop the travel of the needle (and suture catch) in the distal direction.

As the plunger is actuated, and prior to theneedle541 being disengaged from the plunger, a distal piercingportion547 of theneedle541, and in some cases, at least the first wrap of the coiled portion of thesuture542, punctures the leaflet L and forms an opening in the leaflet L (see e.g.,FIG. 28B). The distance the distal piercingportion547 of theneedle541 extends within the left atrium on the distal side of the leaflet L can be determined, for example, by the preset allowed amount of travel of theneedle541 described above (e.g., in some embodiments, the amount of travel can be determined at least in part by a stop member within the handle and/or a mechanism to release the needle hub from the plunger). In some embodiments, thedelivery device530 can be configured to advance the distal piercingportion547 of the needle541 a shorter distance into the left atrium than as shown and described above for the embodiment ofFIGS. 6-10. For example, in some embodiments, theneedle hub543 can travel about 0.25 inches during actuation of the plunger. In some embodiments, theneedle541 can be extended outside of the distal end of the delivery device (e.g., beyond the end effector) half the distance that is shown and described for the embodiment ofFIGS. 6-10. In some embodiments, theneedle541 can be extended outside the delivery device a distance of about 0.2-0.3 inches (e.g., 0.25 inches).

As described above, when theneedle hub543, theneedle541 andsuture catch546 disengage from the plunger, the plunger continues to be moved distally, which in turn moves thepusher537, thepusher hub539, and the coiled portion of the suture542 (e.g., distal anchor540) further distally. For example, in some embodiments, thepusher537 can be moved distally about an additional 0.25-0.65 inches (e.g., 0.4 inches) during actuation of the plunger. Thus, in some embodiments, the total travel of the pusher can be, for example, about 0.40-0.90 inches (e.g., 0.65 inches). Similarly, in some embodiments, the pusher can be extended through the proximal side of the heart valve leaflet a distance of about 0.4-0.9 inches (e.g., 0.65 inches) from the proximal side of the heart valve leaflet. As yet a further example of the short throw deployment sequence, the pusher can be moved through the opening of the leaflet from the proximal side of the leaflet and can extend a distance of about 0.25-0.65 inches (e.g., 0.4 inches) from and distal to the distal side of the leaflet.

As thepusher537 is moved distally, with thesuture catch546, theneedle541 and theneedle hub543 in fixed positions relative to the pusher537 (i.e., thesuture catch546, theneedle541, and theneedle hub543 are disengaged from the plunger), a distal end of thepusher537 moves or pushes the distal coiled portion of the suture542 (i.e., distal anchor540) over the distal end of theneedle541 and further within the left atrium of the heart on a distal side of the mitral leaflet (seeFIG. 28C). In this manner, the distal end of thepusher537 pushes the coiled portion of the suture542 (i.e., distal anchor540) distally off theneedle541. To allow the distal coiled portion of the suture542 (i.e., distal anchor540) to slide relative to and eventually off theneedle541, when thesuture542 is loaded within thedelivery device530, there can be slack formed in thesuture542 between the distal coiled portion of thesuture542 and the suture lock within thesuture catch546. As shown inFIG. 28D, as thepusher537 continues to move distally relative to theneedle541, the coiled portion of thesuture542 forms the bulky knot configuration of thedistal anchor540 by approximating opposite ends of the coils of the elongated coil portion of thesuture542 towards each other, to form one or more loops (two loops are shown inFIG. 28D). For example, with the opposite end portions of thesuture542 fixed and secured within thesuture catch546, as thepusher537 moves distally, the coils are forced against the distal end of thepusher537 to form the knot.

In use, in some instances, the plunger can be actuated to move theneedle hub543 as described above, while maintaining the entire distal portion of thedelivery device530 on the ventricular side of the leaflet L. In this manner, in such instances, thedistal anchor540 can be delivered to and/or deployed at the distal side of the leaflet without some form of mechanical fixation to and/or capturing of the leaflet L prior to piercing the leaflet with theneedle541. Unlike conventional open-heart surgery, where the heart is stopped and the surgeon can see and manipulate stationary leaflets, in a minimally invasive procedure (e.g., with a beating heart), the operator cannot see the leaflet directly, and instead, must rely on an ultrasonic or other image of the moving leaflet and the device. In practice, this image is often displayed on a display device for the operator after a slight time delay. As such, immobilizing the otherwise moving leaflet can be challenging and has the potential to further damage the leaflet. Being able to deliver and deploy a distal anchor without having to mechanically fix to and/or capture the otherwise moving leaflet (e.g., prior to piercing the leaflet to form an opening through with the distal anchor is delivered) eliminates or at least limits the challenges discussed above. Additionally, being able to deliver and deploy the distal anchor using a single device (e.g., without using a separate device to immobilize and/or capture the leaflet) further reduces challenges and risks associated with such procedures.

After thedistal anchor540 has formed a knot, the proximal end portions of thesuture542 can be released from thesuture catch546 and thedelivery device530 can be withdrawn proximally, leaving thedistal anchor540 disposed on the distal side of the leaflet L (as shown inFIG. 28E), and two lengths or strands of thesuture532 extending out of the heart. In other words, with thesuture542 released from thesuture catch546 thedelivery device530 can be slid proximally over thesuture542 for removal. Forming/deploying the bulky knot using the full forward short throw deployment sequence described above can simplify the procedure for an operator of thedelivery device530 because the operator can deploy the bulky knot by applying a single distal force to the plunger. Further, after the plunger is actuated and the bulky knot is formed, the operator can remove thedelivery device530 from the patient by withdrawing thedelivery device530 proximally without, for example, having to wait for the plunger to move proximally to form the bulky knot, leaving the bulky knot disposed on the distal side of the leaflet L. Simplifying a procedure in this manner such that an operator can implant an artificial chorda by applying, for example, a push force to the plunger, and then remove the entire delivery device by withdrawing the delivery device proximally, promotes a repeatable and predicable procedure.

As described above for previous embodiments, the lengths or strands of thesuture542 between thedistal anchor540 and the opening in the heart can be adjusted until the desired length is established. The proximal ends of thesuture542 can then be secured to an outer surface of the heart at, for example, the apex region, with a proximal anchor (not shown). The proximal anchor can be, for example, a pledget, one or more knots, or other suitable anchoring device. As previously described, the above procedure can be performed multiple times on the same leaflet, and/or can be performed on the other mitral valve leaflet in the same manner. The result can thus be that one or more anchor-tether apparatuses (e.g., anchor-tether apparatus145) as described above are each anchored on a distal side of a leaflet with adistal anchor540 and secured to the apex of the heart with a proximal anchor via thetether542. Alternatively, if one or more anchor-tether apparatus are attached to both mitral valve leaflets, an anchor-tether apparatus attached to each leaflet can be secured together in the heart by tying them together with knots or by another suitable attachment member (not shown), creating an edge-to-edge repair to decrease the septal-lateral distance of the mitral valve orifice. The two attached anchor-tether apparatus can be left loose or tensioned to create a “facilitated” edge-to-edge repair before being secured to an outer surface of the heart with a proximal anchor.

In some embodiments, the suture catch can be coupled in a fixed position relative to the handle of the delivery device, rather than being coupled to the plunger. Thus, the proximal portion of the suture coupled to the suture catch is in a fixed position relative to the handle. In such embodiments, there can be sufficient slack formed in the suture between the distal coiled portion of the suture and the suture lock within the suture catch to allow the distal coiled portion of the suture (i.e., distal anchor) to slide relative to and eventually off the needle, when the plunger is advanced distally. Alternatively or in addition to, providing slack in the suture, a spring can be disposed in the handle and coupled to the suture between the distal coiled portion of the suture (i.e., the distal anchor) and the suture lock, which can expand longitudinally as the plunger is moved distally.

FIGS. 28A-28E described above illustrate one example method and device for deploying a bulky knot distal anchor using a delivery device that utilizes a full forward short throw deployment sequence configured to insert the distal end portion and piercing member of the needle a shorter distance into the left atrium than as shown and described above for the embodiment ofFIGS. 6-10. Such a full forward short throw delivery sequence is configured to cause the bulky knot distal anchor to be deployed/formed by moving the pusher distally relative to the needle rather than pulling on the proximal ends of the suture to pull the coils against the distal end of the pusher. In another embodiment, a bulky knot distal anchor can be deployed/formed using a delivery device that utilizes an independent full forward short throw deployment sequence. The independent full forward short throw deployment sequence is similar to the full forward short throw deployment sequence ofFIGS. 28A-28E, except the pusher and the needle are configured to move independent of each other (e.g., the pusher and the needle can each be coupled to a different component of the actuator and/or be actuated separately). For example, the pusher and needle can be moved within the handle and the outer tube independently of each other and during varying time periods in response to separate force-providing mechanisms.FIGS. 29A-29E are schematic illustrations of an embodiment of a delivery device for delivering and deploying a distal anchor using an independent full forward short throw deployment sequence.

As shown inFIGS. 29A-29E, a delivery device630 includes a distal end portion632, a proximal end portion636 and a medial portion634. The distal end portion632 includes anend effector633 that can be placed in contact with a leaflet L of a mitral valve as described above with respect to previous embodiments. Theend effector633 is coupled to a distal end portion of anouter tube631 and a proximal end portion of theouter tube631 is coupled to ahandle635 at the proximal end portion636 of the delivery device630. Theend effector633 can distribute the force of theouter tube631 over a larger area to prevent/eliminate puncturing of the leaflet with the delivery device630 during deployment. In some embodiments, theend effector633 can include a balloon (not shown). Anelongate pusher637 is movably disposed within a lumen of theouter tube631 and is coupled to apusher hub639 that is movably disposed within thehandle635 and coupled to an actuator (not shown). The actuator can be used to actuate or move thepusher hub639 and thepusher637 during deployment of adistal anchor640 and can be movably disposed at least partially within the handle. A needle641 (seeFIG. 29B) is movably disposed within a lumen of thepusher637 and is coupled to aneedle hub643 that is coupled to an actuator (not shown) and/or energy storage member (not shown). The actuator can be used to actuate or move theneedle hub643 and the needle641 (both independent of the pusher hub and the pusher) during deployment of thedistal anchor640 and can be movably disposed at least partially within thehandle635. For example, thehandle635 can define a lumen in which the actuator or a portion of the actuator can be actuated and/or moved. The delivery device630 can also include a locking lever (not shown) that can be used to prevent the actuator(s) and/or one or more of its constituent components from actuating and/or moving within or relative to thehandle635 during, for example, storage and/or prior to performing a procedure to deploy the distal anchor. For example, the locking lever can be similar to or the same as the lockinglever449 described above.

A suture catch646 (also referred to as “tether catch”) can be coupled to a proximal end of the delivery device630. Thesuture catch646 is configured to releasably hold or secure asuture642 extending through the delivery device630 during delivery of thedistal anchor640 as described above for previous embodiments. In some embodiments, thesuture catch646 can hold thesuture642 with a friction fit or with a clamping force and can have a lock that can be released after thedistal anchor640 has been deployed/formed into a bulky knot.

As described above for previous embodiments, the suture642 (also referred to herein as “tether”) can be formed into an elongated coiled configuration and is disposed within theouter tube631 at the distal end portion632 of the delivery device630. As described above, for example, forsuture242, two strands of thesuture642 can extend from the distal elongated coiled portion of thesuture642, and extend through the lumen of theneedle641. The distal elongated coiled portion of thesuture642 will be formed into the distal anchor640 (e.g., bulky knot) upon actuation of the delivery device630 as described in more detail below. As discussed above for previous embodiments, thedistal anchor640 can be in the form of one or more multi-turn coils of thesuture642 that can be changed from the elongated coiled configuration during delivery to a knot configuration by approximating opposite ends of the coils towards each other, to form one or more loops.

To deliver and form thedistal anchor640 within, for example, a left atrium of the heart to repair a mitral valve, the distal end portion of632 of the delivery device630 can be inserted through an apex portion of the heart and into the left ventricle until theend effector633 contacts a proximal side of the mitral valve leaflet L as shown inFIG. 29A. In this embodiment, with the delivery device630 positioned against only the ventricular side of the mitral leaflet L, and with a proximal end portion of the suture642 (e.g., two suture strands of suture642) secured to thesuture catch646, the actuator can be actuated and/or moved to move both theneedle hub643 and theneedle641 distally relative to thehandle635, thepusher hub639 and thepusher637. Theneedle hub643 and the needle641 (with the coiled portion of thesuture642 coupled thereto) are moved distally until theneedle hub643 andneedle641 reach a preset location within thehandle635, at which point their travel in the distal direction is stopped.

In some embodiments, the delivery device can also include one or more stop members within the handle that can engage or contact the needle hub to limit or stop the travel of the needle in the distal direction.

As theneedle641 is advanced distally within thehandle635, a distal piercing portion (not shown) of theneedle641, and in some cases, at least the first wrap of the coiled portion of thesuture642, punctures the leaflet L and forms an opening in the leaflet L (see e.g.,FIG. 29B). The distance the distal piercing portion of theneedle641 extends within the left atrium on the distal side of the leaflet L can be determined, for example, by the preset allowed amount of travel of theneedle641 described above (e.g., in some embodiments, the amount of travel can be determined at least in part by a stop member within the handle and/or a mechanism disposed within thehandle635. In some embodiments, the delivery device630 can be configured to advance the distal piercing portion of the needle641 a shorter distance into the left atrium than as shown and described above for the embodiment ofFIGS. 6-10. For example, in some embodiments, theneedle hub643 can travel about 0.25 inches. In some embodiments, the needle can be extended outside of the distal end of the delivery device (e.g., beyond the end effector) half the distance that is shown and described for the embodiment ofFIGS. 6-10. In some embodiments, the needle can be extended outside the delivery device a distance of about 0.2-0.3 inches (e.g., 0.25 inches).

With a portion of theneedle641 disposed within the left atrium, an actuator (not shown) (e.g. a plunger or other type of actuator mechanism) can be actuated and/or moved to cause thepusher hub639 and in turn thepusher637 to move distally within thehandle635 and relative to theneedle641 andneedle hub643, as shown byFIG. 29C. In this manner, thepusher637 can urge the coiled portion of the suture642 (e.g., the distal anchor640) further distally relative to theneedle641, as described in further detail herein. For example, in some embodiments, with theend effector633 in contact with the proximal side of the mitral valve leaflet L, thepusher637 can be moved distally about 0.65 inches.

As thepusher637 is moved distally, with thesuture catch646, theneedle641 and theneedle hub643 in fixed positions relative to thepusher637, a distal end of thepusher637 moves or pushes the distal coiled portion of the suture642 (i.e., distal anchor640) over the distal end of theneedle641 and further within the left atrium of the heart on a distal side of the mitral leaflet (seeFIG. 29C). In this manner, the distal end of thepusher637 pushes the coiled portion of the suture642 (i.e., distal anchor640) distally off theneedle641. To allow the distal coiled portion of the suture642 (i.e., distal anchor640) to slide relative to and eventually off theneedle641, when thesuture642 is loaded within the delivery device630, there can be slack formed in thesuture642 between the distal coiled portion of thesuture642 and the suture lock within thesuture catch646. As shown inFIG. 29D, as thepusher637 continues to move distally relative to theneedle641, the coiled portion of thesuture642 forms the bulky knot configuration of thedistal anchor640 by approximating opposite ends of the coils of the elongated coil portion of thesuture642 towards each other, to form one or more loops (two loops are shown inFIG. 29D). For example, with the opposite end portions of thesuture642 fixed and secured within thesuture catch646, as thepusher637 moves distally, the coils are forced against the distal end of thepusher637 to form the knot.

After thedistal anchor640 has formed a knot, the proximal end portions of thesuture642 can be released from thesuture catch646 and the delivery device630 can be withdrawn proximally, leaving thedistal anchor640 disposed on the distal side of the leaflet L (as shown inFIG. 29E), and two lengths or strands of the suture632 extending out of the heart. In other words, with thesuture642 released from thesuture catch646, the delivery device630 can be slid proximally over thesuture642 for removal. In some embodiments, after thedistal anchor640 has formed a knot, and the proximal end portions of thesuture642 are released from thesuture catch646, theneedle641 and/or thepusher637 can be withdrawn proximally within and relative to theouter tube631. In some instances, theneedle641 and/or thepusher637 are withdrawn proximally into theouter tube631 before the delivery device630 is withdrawn proximally, while in other instances, theneedle641 and/or thepusher637 are withdrawn proximally into theouter tube631 as the delivery device630 is withdrawn proximally.

As described above for previous embodiments, the lengths or strands of thesuture642 between thedistal anchor640 and the opening in the heart can be adjusted until the desired length is established. The proximal ends of thesuture642 can then be secured to an outer surface of the heart at, for example, the apex region, with a proximal anchor (not shown). The proximal anchor can be, for example, a pledget, one or more knots, or other suitable anchoring device. As previously described, the above procedure can be performed multiple times on the same leaflet, and/or can be performed on the other mitral valve leaflet in the same manner. Thus, as a result, one or more anchor-tether apparatuses (e.g., anchor-tether apparatus145) can be anchored on a distal side of a leaflet with adistal anchor640 and secured to the apex of the heart with a proximal anchor via thetether642. Alternatively, if one or more anchor-tether apparatus are attached to both mitral valve leaflets, an anchor-tether apparatus attached to each leaflet can be secured together in the heart by tying them together with knots or by another suitable attachment member (not shown), creating an edge-to-edge repair to decrease the septal-lateral distance of the mitral valve orifice. The two attached anchor-tether apparatus can be left loose or tensioned to create a “facilitated” edge-to-edge repair before being secured to an outer surface of the heart with a proximal anchor.

In some embodiments, alternatively or in addition to providing slack in the suture, a spring can be disposed in the handle and coupled to the suture between the distal coiled portion of the suture (i.e., the distal anchor) and the suture lock, which can expand longitudinally as the distal anchor is moved distally relative to the handle as described above.

In another embodiment, a bulky knot distal anchor can be deployed/formed using a delivery device that utilizes an independent short throw deployment sequence. The independent short throw deployment sequence is similar to the independent full forward short throw deployment sequence ofFIGS. 29A-29E, except the bulky knot distal anchor is deployed/formed by pulling on the proximal ends of the suture to pull the coils against the distal end of the pusher rather than moving the pusher distally relative to the needle. Similar to the embodiment ofFIGS. 29A-29E, for example, the pusher and needle can be moved within the outer tube independently of each other and during varying time periods in response to separate force-providing mechanisms and/or separate energy storage members. Further, similar to the embodiment ofFIGS. 14A-14E, the needle can be moved proximally within and relative to the handle, pulling the suture (e.g., suture strands extending from the coiled portion of the suture) proximally through the pusher to form the bulky knot configuration of the distal anchor.FIGS. 30A-30E are schematic illustrations of an embodiment of a delivery device for delivering and deploying a distal anchor and configured to provide such an independent short throw deployment sequence.

As shown inFIGS. 30A-30E, a delivery device730 includes a distal end portion732, a proximal end portion736 and a medial portion734. The distal end portion732 includes anend effector733 that can be placed in contact with a leaflet L of a mitral valve as described above with respect to previous embodiments. Theend effector733 is coupled to a distal end portion of anouter tube731 and a proximal end portion of theouter tube731 is coupled to ahandle735 at the proximal end portion736 of the delivery device730. Theend effector733 can distribute the force of theouter tube731 over a larger area to prevent/eliminate puncturing of the leaflet with the delivery device730 during deployment. In some embodiments, theend effector733 can include a balloon (not shown). Anelongate pusher737 is movably disposed within a lumen of theouter tube731 and is coupled to apusher hub739 that is movably disposed within thehandle735 and coupled to an actuator (not shown) and/or energy storage member (not shown). The actuator and/or energy storage member can be used to actuate or move thepusher hub739 and thepusher737 during deployment of adistal anchor740 and can be movably disposed at least partially within the handle. A needle741 (seeFIG. 30B) is movably disposed within a lumen of thepusher737 and is coupled to aneedle hub743 that is coupled to an actuator (not shown). The actuator can be used to actuate or move theneedle hub743 and the needle741 (both independent of the pusher hub and the pusher) during deployment of thedistal anchor740 and can be movably disposed at least partially within thehandle735. For example, thehandle735 defines a lumen in which the actuator or a portion of the actuator can be actuated and/or moved. The delivery device730 can also include a locking lever (not shown) that can be used to prevent the actuator and/or one or more of its constituent components from actuating and/or moving within or relative to thehandle735 during storage and prior to performing a procedure or a particular portion thereof to deploy the distal anchor. For example, the locking lever can be similar to or the same as the lockinglever449 described above.

A suture catch746 (also referred to as “tether catch”) can be coupled to a proximal end of the delivery device730. Thesuture catch746 is configured to releasably hold or secure asuture742 extending through the delivery device730 during delivery of thedistal anchor740 as described above for previous embodiments. In some embodiments, thesuture catch746 can hold thesuture742 with a friction fit or with a clamping force and can have a lock that can be released after thedistal anchor740 has been deployed/formed into a bulky knot.

As described above for previous embodiments, the suture742 (also referred to herein as “tether”) can be formed into an elongated coiled configuration and is disposed within theouter tube731 at the distal end portion732 of the delivery device730. As described above, for example, forsuture242, two strands of thesuture742 can extend from the distal elongated coiled portion of thesuture742, and extend through the lumen of theneedle741. The distal elongated coiled portion of thesuture742 will be formed into the distal anchor740 (e.g., bulky knot) upon actuation of the delivery device730 as described in more detail below. As discussed above for previous embodiments, thedistal anchor740 can be in the form of one or more multi-turn coils of thesuture742 that can be changed from the elongated coiled configuration during delivery to a knot configuration by approximating opposite ends of the coils towards each other, to form one or more loops.

To deliver and form thedistal anchor740 within, for example, a left atrium of the heart to repair a mitral valve, the distal end portion of732 of the delivery device730 can be inserted through an apex portion of the heart and into the left ventricle until theend effector733 contacts a proximal side of the mitral valve leaflet L as shown inFIG. 30A. In this embodiment, with the delivery device730 positioned against only the ventricular side of the mitral leaflet L, and with a proximal end portion of the suture742 (e.g., two suture strands of suture742) secured to thesuture catch746, the actuator and/or energy storage member can be actuated and/or moved to move both theneedle hub743 and theneedle741 distally relative to thehandle735, thepusher hub739 and thepusher737. Theneedle hub743 and the needle741 (with the coiled portion of thesuture742 coupled thereto) are moved distally until theneedle hub743 andneedle741 reach a preset location within thehandle735, at which point their travel in the distal direction is stopped.

In some embodiments, the delivery device can also include one or more stop members within the handle that can engage or contact the needle hub to limit or stop the travel of the needle in the distal direction.

As theneedle741 is advanced distally within thehandle735, a distal piercing portion (not shown) of theneedle741, and in some cases, at least the first wrap of the coiled portion of thesuture742, punctures the leaflet L and forms an opening in the leaflet L (see e.g.,FIG. 30B). The distance the distal piercing portion of theneedle741 extends within the left atrium on the distal side of the leaflet L can be determined, for example, by the preset allowed amount of travel of theneedle741 described above (e.g., in some embodiments, the amount of travel can be determined at least in part by a stop member within the handle and/or a mechanism disposed within the handle735). In some embodiments, the delivery device730 can be configured to advance the distal piercing portion of the needle741 a shorter distance into the left atrium than as shown and described above for the embodiment ofFIGS. 6-10. For example, in some embodiments, theneedle hub743 can travel about 0.25 inches. In some embodiments, the needle can be extended outside of the distal end of the delivery device (e.g., beyond the end effector) half the distance that is shown and described for the embodiment ofFIGS. 6-10. In some embodiments, the needle can be extended outside the delivery device a distance of about 0.2-0.3 inches (e.g., 0.25 inches).

With a portion of theneedle741 disposed within the left atrium, an actuator (not shown) can be actuated and/or moved to cause thepusher hub739 and in turn thepusher737 to move distally within thehandle735 and relative to theneedle741 andneedle hub743, as shown byFIG. 30C. In this manner, the distal end portion of thepusher737 can urge, push, or otherwise move the coiled portion of the suture742 (e.g., the distal anchor740) off and distal to theneedle741, as described in further detail herein. For example, in some embodiments, with theend effector733 in contact with the proximal side of the mitral valve leaflet L, and theneedle741 in a fixed position relative to thepusher737, thepusher737 can be moved distally about 0.65 inches.

As thepusher737 is moved distally, and with thesuture catch746, theneedle741 and theneedle hub743 in fixed positions relative to thepusher737, a distal end of thepusher737 moves or pushes the distal coiled portion of the suture742 (i.e., distal anchor740) over the distal end of theneedle741 and further within the left atrium of the heart on a distal side of the mitral leaflet (seeFIG. 30C). In other words, the distal end of thepusher737 and the distal coiled portion of thesuture742 extend beyond the distal end of theneedle741. For example, in some embodiments, at least half a length of the distal coiled portion of thesuture742 extends beyond the distal end of theneedle741. In some embodiments, at least three quarters of the length of the distal coiled portion of thesuture742 extends beyond the distal end of theneedle741. In other embodiments, the entire length of the distal coiled portion of thesuture742 extends beyond the distal end of theneedle741. To allow the distal coiled portion of the suture742 (i.e., distal anchor740) to slide relative to and eventually off theneedle741, when thesuture742 is loaded within the delivery device730, there can be slack formed in thesuture742 between the distal coiled portion of thesuture742 and the suture lock within thesuture catch746.

After the distal coiled portion of thesuture742 is moved to the distal side of the leaflet L, theneedle hub743 and theneedle741 are moved proximally relative to thepusher737, pulling the suture742 (e.g., suture strands extending from the coiled portion of the suture742) through thepusher737 to form the bulky knot configuration (as shown inFIG. 30D) of thedistal anchor740 by approximating opposite ends of the coils of the elongated coil portion of thesuture742 towards each other, to form one or more loops. As shown inFIG. 30D, by pulling on the proximal ends of thesuture742, the coils are pulled against the distal end of thepusher737 to form the knot. After thedistal anchor740 has formed a knot, the proximal end portions of thesuture742 can be released from thesuture catch746 and the delivery device730 can be withdrawn proximally, leaving thedistal anchor740 disposed on the distal side of the leaflet L (as shown inFIG. 30E), and two lengths or strands of the suture732 extending out of the heart. In other words, with thesuture742 released from thesuture catch746, the delivery device730 can be slid over thesuture742 for removal.

In some embodiments, after thedistal anchor740 has formed a knot, and the proximal end portions of thesuture742 are released from thesuture catch746, theneedle741 and/or thepusher737 can be withdrawn proximally within and relative to theouter tube731. In some instances, theneedle741 and/or thepusher737 are withdrawn proximally into theouter tube731 before the delivery device730 is withdrawn proximally, while in other instances, theneedle741 and/or thepusher737 are withdrawn proximally into theouter tube731 as the delivery device730 is withdrawn proximally.

As described above for previous embodiments, the lengths or strands of thesuture742 between thedistal anchor740 and the opening in the heart can be adjusted until the desired length is established. The proximal ends of thesuture742 can then be secured to an outer surface of the heart at, for example, the apex region, with a proximal anchor (not shown). The proximal anchor can be, for example, a pledget, one or more knots, or other suitable anchoring device. As previously described, the above procedure can be performed multiple times on the same leaflet, and/or can be performed on the other mitral valve leaflet in the same manner. As a result, one or more anchor-tether apparatuses (e.g., anchor-tether apparatus145) as described above are each anchored on a distal side of a leaflet with adistal anchor740 and secured to the apex of the heart with a proximal anchor via thetether742. Alternatively, if one or more anchor-tether apparatus are attached to both mitral valve leaflets, an anchor-tether apparatus attached to each leaflet can be secured together in the heart by tying them together with knots or by another suitable attachment member (not shown), creating an edge-to-edge repair to decrease the septal-lateral distance of the mitral valve orifice. The two attached anchor-tether apparatus can be left loose or tensioned to create a “facilitated” edge-to-edge repair before being secured to an outer surface of the heart with a proximal anchor.

In some embodiments, alternatively or in addition to providing slack in the suture, a spring can be disposed in the handle and coupled to the suture between the distal coiled portion of the suture (i.e., the distal anchor) and the suture lock, which can expand longitudinally as the distal anchor is moved distally relative to the handle as described above.

FIG. 31 shows a schematic illustration of a distal anchor840 shown in an elongated coiled configuration. The distal anchor840 can be delivered and deployed within a heart using any of the delivery devices described herein. For ease of explanation, the distal anchor840 is shown and described with reference to afirst section860 of the suture842 and asecond section870 of the suture842. Thefirst section860 has a first portion861 (as shown in dashed line for ease of illustration) and asecond portion862 including afirst coil863 formed of multiple turns about the exterior of thedistal end portion832 of the delivery device830. Thefirst coil863 has aproximal end864 and adistal end865. Thesecond portion862 of thefirst section860 has a first end866 at thedistal end865 of thefirst coil863.

Thesecond section870 has asecond portion872 with a first end876, and extends proximally from the first end866 of thefirst section860 through an interior of the first coil863 (and through the lumen of thedistal end portion832 of the deliver device830) to theproximal end864 of thefirst coil863. Thesecond section870 also includes aloop forming segment877 that extends distally from afirst end878 of theloop forming segment877 at theproximal end864 of thefirst coil863 along the outside of thefirst coil863 to thedistal end865 of thefirst coil863, and extends proximally through the interior of the first coil863 (and through the lumen of thedistal end portion832 of the deliver device830) to theproximal end864 of thefirst coil863 at asecond end879 of theloop forming segment877.

Thesecond portion872 of thesecond section870 includes asecond coil873 formed of multiple turns about the exterior of thedistal end portion832 of the delivery device830 proximal to thefirst coil863, and has aproximal end874 and adistal end875. Thesecond portion872 of thesecond section870 extends proximally from the first end876 of thesecond portion872 through the interior of the second coil873 (and as shown inFIGS. 32A-32E, e.g., through the lumen of thedistal end portion832 of the deliver device830) to theproximal end874 of thesecond coil873. Thefirst end878 of theloop forming segment877 of thesecond portion872 of thesecond section870 extends from thedistal end875 of thesecond coil873.

Thesecond portion862 of thefirst section860 has aloop forming segment867 that extends from afirst end868 of theloop forming segment867 of thesecond portion862 of thefirst section860 proximally from theproximal end864 of thefirst coil863 along the outside of thesecond coil873 to theproximal end874 of thesecond coil873 and extends distally through the interior of the second coil873 (and as shown inFIGS. 32A-32E, e.g., through the lumen of thedistal end portion832 of the delivery device830) to thedistal end875 of thesecond coil873 at asecond end869 of theloop forming segment867 of thesecond portion862 of thefirst section860. Thefirst portion861 of thefirst section860 extends proximally from thesecond end869 of theloop forming segment867 of thesecond portion862 of thefirst section860.

FIGS. 32A-32E illustrate in sequence the formation of the distal anchor840 ofFIG. 31 about an exterior of a needle841 of a delivery device (not shown) and in an elongated coiled configuration (FIG. 32E). The needle841 defines a lumen L therethrough and a slot (not shown) in communication with the lumen L. To form the distal anchor840 about the needle841, thesecond portion872 of thesecond section870 of the suture842 is routed through the lumen L of the needle841 (see e.g.,FIG. 32A). Next, thesecond portion862 of thefirst section860 of the suture842 is wrapped about the needle841 to form the first coil863 (see e.g.,FIG. 32B). Similarly, thesecond portion872 of thesecond section870 of the suture842 is wrapped about the needle841 proximate to thefirst coil863 to form the second coil873 (see e.g.,FIG. 32C).

After formation of thefirst coil863 and thesecond coil873 about the needle841, theloop forming segment867 of thesecond portion862 of thefirst section860 is formed by routing proximally thesection portion862 of thefirst section860 of the suture842 from theproximal end864 of and exterior to thefirst coil863 towards theproximal end874 of the second coil873 (see e.g.,FIG. 32C), and then extending distally through the interior of the second coil (see e.g.,FIG. 32D). In a similar manner, theloop forming segment877 of thesecond portion872 of thesecond section870 is formed by routing distally thesecond portion872 of thesecond section870 of the suture842 from thedistal end875 of thesecond coil873 towards thedistal end865 of the first coil863 (see e.g.,FIG. 32C), and then extending proximally through the interior of thefirst coil863 to theproximal end864 of the first coil863 (see e.g.,FIG. 32D). Thefirst portion861 of thefirst section860 of the suture842 and the first portion871 (as shown in dashed line for ease of illustration) of thesecond section870 of the suture842 extends from the lumen L of the needle841 through the slot (not shown) of the needle841 to an area external to the needle841 such that eachportion861,871 can be manipulated (e.g., pulled proximally) to form the knot, as described above.

FIGS. 33A-33D illustrate an example method of preparing a delivery device930 to deliver a distal anchor940 (e.g., and to form a bulky knot distal anchor) to be disposed on a distal side of a mitral valve leaflet. The delivery device930 can be constructed the same as or similar to, and function the same as or similar to, for example, thedelivery device430 or any other delivery device described herein. It should be understood that for features and functions not specifically discussed with respect to the delivery device930, those features and functions can be the same as or similar to thedelivery device430 or any of the delivery devices described herein.

Theguide member955 is configured to be coupled to the proximal end of apusher hub939 as illustrated by arrow A inFIG. 33A and disposed within a lumen defined by the biasingmember990 shown inFIG. 30B. As illustrated inFIG. 33B, the biasingmember990 is configured to be slid over theneedle941 that is coupled to a needle hub (not shown) disposed within aplunger948.

To couple thepusher hub939 to theplunger948, thepusher hub939 is slid over theneedle941 towards the distal end of theplunger948, as shown by arrow B inFIG. 33C, until theguide member955 and the biasingmember990 are inserted into a lumen defined by theplunger948 and the tabs985 of thepusher hub939 are aligned with corresponding slots (not shown) defined by theplunger948. As thepusher hub939 is slid towards and eventually coupled to theplunger948, the biasingmember990 is compressed or otherwise loaded with potential energy. Although not shown inFIGS. 33A-33D, the delivery device930 can include a handle, and similar to as described herein with respect to thetabs485 and thehandle435 ofFIGS. 17A and 18A, when thepusher hub939 is coupled to the plunger948 (as shown byFIG. 33D), the tabs are compressed by the inner walls of the handle. As illustrated in detailed view byFIG. 33E, theneedle941 is movably disposed within the lumen defined by thepusher937.

FIGS. 34A-34H illustrate an example method of forming the distal anchor940 in an elongated coiled configuration (FIG. 34H) about an exterior of theneedle941. The distal anchor940 (formed of a suture942) and theneedle941 can be constructed similar to or the same as and function similar to or the same as any of the distal anchors and needles described herein with respect to previous embodiments. Theneedle941 defines an interior lumen L, and a distal portion of theneedle941 includes a slot SL in communication with the lumen. As shown inFIG. 34A, thesecond portion972 of the second section970 of thesuture942 is routed through the slot SL of theneedle941 and between the knot rings980. The knot rings980 (e.g., silicone O-rings) are disposed about thesuture942 and theneedle941 to secure thesuture942 to and within the slot SL of theneedle941. In this manner, the knot rings980 define the outer edges (or thedistal end965 of thefirst coil963 and theproximal end974 of the second coil973) of the distal anchor940, and can secure thesuture942 such that thefirst coil963 and thesecond coil973 can be formed about theneedle941.

To form thefirst coil963 and thesecond coil973, theneedle941 is rotated such that the free ends (or thesecond portion962 of the first section960 and thesecond portion972 of the second section970) of thesuture942 form multiple turns about the exterior of theneedle941, as shown inFIG. 34B. Next, theloop forming segment967 of thesecond portion962 of the first section960 is formed by routing proximally thesecond portion962 of the first section960 of thesuture942 from theproximal end964 of and exterior to thefirst coil963 towards theproximal end974 of thesecond coil973, and then extending distally through the interior of thesecond coil973 to thedistal end975 of thesecond coil973, as shown inFIG. 34C. In a similar manner, theloop forming segment977 of thesecond portion972 of the second section970 is formed by routing distally thesecond portion972 of the second section970 of thesuture942 from thedistal end975 of thesecond coil973 towards thedistal end965 of thefirst coil963, and then extending proximally through the interior of thefirst coil963 to theproximal end964 of thefirst coil963, as shown inFIG. 34D.

To further prepare the distal anchor940 for delivery to a heart, as described in previous embodiments, the loop forming segments can be shortened and/or tightened by pulling thefirst portion961 of the first section960 of thesuture942 and thefirst portion971 of the second section970 of thesuture942. Such a configuration is shown inFIG. 34E. Once theloop forming segments967,977 are formed, the knot rings980 can be removed from the needle932 and thesuture942. Upon removal of the knot rings980, theloop forming segments967,977 can be further shortened or tightened, as shown inFIGS. 34F and 34G. Next, thefirst portion961 of the first section960 of thesuture942 and thefirst portion971 of the second section970 of thesuture942 can be routed proximally into a distal end of the interior lumen L of theneedle941 and proximally through the interior lumen L, as shown inFIGS. 34G and 34H.

In some embodiments, asnare993 can be used to facilitate routing of thesuture942 and forming of thedistal anchor942, as illustrated inFIGS. 34C, 34D, and 34 G. For example, thesnare993 can be used to route thefirst portion961 of the first section960 and thefirst portion971 of the second section970 into the interior lumen L of the needle and proximally through the interior lumen L.

In another embodiment of a distal anchor, the circumferential windings of the knot in the knot distal anchor940 described above are replaced by a single flexible tube. Such an embodiment of a distal anchor is illustrated inFIGS. 35 and 36.FIG. 35 illustrates adistal anchor1040 in an elongated delivery configuration, andFIG. 36 illustrates thedistal anchor1040 in a deployed configuration. In this embodiment, theflexible tube1044 has adistal portion1045, and aproximal portion1056, and aslit1046 separating thedistal portion1045 from theproximal portion1056. In an alternative embodiment, instead of a singleflexible tube1044, theanchor1040 can be formed with a separate distal tube and proximal tube (not shown), separated by a gap, rather than a partial circumference slit in a middle portion of a single flexible tube, as shown inFIG. 35. The suture1043 is routed into and through theslit1046, into a lumen of theflexible tube1044, extending distally through the lumen from theslit1045 towards and through adistal end1065 of thedistal portion1045, then extending proximally along the exterior of theflexible tube1044 towards and through aproximal end1074 of theproximal portion1056, then extending distally into and through the lumen of theflexible tube1044 towards and through thedistal end1065 of thedistal portion1045, then extending proximally along the exterior of theflexible tube1044 towards and through theproximal end1074 of theproximal portion1056, and then extending distally through the lumen of theflexible tube1044 towards and through theslit1045 and outside of theflexible tube1044, as shown inFIG. 35.

Similar to the knot distal anchors described above with respect to previous embodiments, thedistal anchor1040 can be deployed in a similar manner using the delivery devices described above with respect to those embodiments. For example, thedistal anchor1040 can be delivered in the elongate configuration (FIG. 35) and moved to the deployed configuration (FIG. 36) by pulling thesuture strands1042 proximally to deflect thedistal end1065 of thedistal portion1045 of theflexible tube1044 laterally with respect to aproximal end1064 of thedistal portion1045 of theflexible tube1044 to draw theproximal end1064 and thedistal end1065 of thedistal portion1045 of theflexible tube1044 towards each other to form a loop L as shown inFIG. 36. Similarly, thesuture strands1042 can be pulled proximally to deflect thedistal end1075 of theproximal portion1056 of theflexible tube1044 laterally with respect to aproximal end1074 of theproximal portion1056 of theflexible tube1044 to draw theproximal end1074 and thedistal end1075 of theproximal portion1056 of theflexible tube1044 towards each other to form a loop L as shown inFIG. 33.

In another embodiment of a distal anchor, the circumferential windings of the knot in the knotdistal anchor240 described above are replaced by a T-fastener, as shown in an elongated delivery configuration inFIG. 37. Similar to the knotdistal anchor240 described above, the distal anchor (or T-fastener)1140 can be deployed in a similar manner using any of the delivery devices described above with respect to previous embodiments. For example, thedistal anchor1140 can be coupled to a suture orsutures1142 and removably coupled to or otherwise in operable contact with apusher1134. Thedistal anchor1140 can be delivered in the elongate configuration and moved to the deployed configuration by pulling thesuture1142 proximally to rotate thedistal anchor1140 such that thedistal anchor1140 is non-parallel with respect to thepusher1134, the distal end portion of the delivery device1130, and/or thesuture1142. Simultaneously, thedistal anchor1140 can be decoupled or otherwise separated from (not shown) thepusher1134 as thepusher1134 is moved distally relative to a handle (not shown) of the delivery device and thesuture1142 is pulled proximally.

In another embodiment of a distal anchor, the circumferential windings of the knot in the knotdistal anchor240 described above are replaced by an expandable distal anchor, as shown inFIGS. 38A-38D.FIG. 38A illustrates thedistal anchor1240 in an elongated delivery configuration disposed within a lumen defined by and disposed through thedistal end portion1232 of the delivery device.FIG. 38B illustrates thedistal anchor1240 in the elongated deliver configuration and disposed outside of and distal to thedistal end portion1232 of the delivery device.FIGS. 38C and 38D illustrate thedistal anchor1240 in a deployed configuration in side and perspective view, respectively. Similar to the knotdistal anchor240 described above, thedistal anchor1240 can be deployed in a similar manner using any of the delivery devices described above with respect to previous embodiments. For example, thedistal anchor1240 can be coupled to a suture1242 (or disposed about thesuture1242 such that thesuture1242 extends through a lumen defined by the distal anchor1240) having astopper1290 disposed at a distal end of thesuture1242. Thesuture1242 is removably coupled to or otherwise in operable contact with apusher1234. Thedistal anchor1240 can be delivered in the elongate configuration (see e.g.,FIGS. 38A and 38B) and moved to the deployed configuration by pulling thesuture1242 proximally and/or moving thepusher1234 distally as shown inFIGS. 38C and 38D. In this manner, both thestopper1290 and thepusher1234 can collectively facilitate the transition of thedistal anchor1240 from the elongated delivery configuration to the radially expanded deployed configuration.

In another embodiment of a distal anchor, the expandabledistal anchor1240 described above is replaced by a double expandable distal anchor, as shown inFIGS. 39A-39C.FIG. 39A illustrates thedistal anchor1340 in an elongated delivery configuration.FIG. 39B illustrates thedistal anchor1340 in a partially deployed configuration.FIG. 39C illustrates thedistal anchor1340 in a deployed configuration. Similar to expandabledistal anchor1240 described above, thedistal anchor1340 can be deployed in a similar manner using, for example, any of the delivery devices described above with respect to previous embodiments. For example, thedistal anchor1340 can be disposed about asuture1342 such that thesuture1342 extends through a lumen defined by thedistal anchor1340, and removably coupled to or otherwise in operable contact with a pusher (not shown). Thedistal anchor1340 can be delivered in the elongate configuration (see e.g.,FIG. 39A) and moved to the deployed configuration (see e.g.,FIGS. 39B and 39C) by pulling thesuture1342 proximally and/or moving the pusher (not shown) distally. In this embodiment, thedistal anchor1340 includes two slits. As thesuture1342 is pulled proximally and/or the pusher (not shown) is moved distally, the slits facilitate expansion of two portions of thedistal anchor1340, as shown inFIG. 39B. In its deployed configuration, the ends of the first slit and the ends of the second slit are brought into or nearly into contact with one another, as shown inFIG. 39C to maximize the expansion of the two portions of thedistal anchor1340.

In use, in some embodiments, thedistal anchor1340 is delivered in the elongate configuration (see e.g.,FIG. 39A) through an opening in a leaflet (e.g., a prolapsed segment of a native mitral valve leaflet) until amedial portion1341 of thedistal anchor1340 is disposed in the opening of the leaflet and a first slit is disposed in the left atrium of the heart and the second slit is disposed in the left ventricle of the heart. Thedistal anchor640 is then moved into its deployed configuration (see e.g.,FIGS. 39B and 39C) such that the two portions (defined in part by the slits) expand radially and/or laterally. In this manner, the two portions of thedistal anchor1340 can collectively grab, grasp, sandwich, or otherwise maintain a portion of the native valve leaflet therebetween. In addition to operably coupling thedistal anchor1340 to the native valve leaflet, thedistal anchor1340 when deployed provides a seal across the opening of the leaflet to prevent or otherwise limit any fluid flow through the opening. In some embodiments, the portions of thedistal anchor1340 can be deployed (e.g., expanded) simultaneously, while in other embodiments the portions of thedistal anchor1340 can be deployed sequentially, e.g., the distal portion can be deployed at a first time and the proximal portion can be deployed at a second time after the first time, or vice versa.

In another embodiment of a distal anchor, the circumferential windings of the knot in the knotdistal anchor240 described above are replaced by an expandable distal anchor (or umbrella anchor), as shown inFIGS. 40A-37C.FIG. 40A illustrates thedistal anchor1440 in an elongated collapsed delivery configuration and proximate to adistal end portion1432 of a delivery device.FIG. 40B illustrates thedistal anchor1440 in a partially deployed configuration.FIG. 40C illustrates thedistal anchor1440 in a deployed or expanded configuration and disposed distal to a valve leaflet VL. In this embodiment, during delivery of thedistal anchor1440, the interior walls of thedistal end portion1432 can retain thedistal anchor1440 in its elongated delivery configuration when thedistal anchor1440 is disposed within a lumen defined by thedistal end portion1432. When in the elongated delivery configuration, anopen end portion1440aof thedistal anchor1440 is disposed proximal to a roundeddistal end1440bof the distal anchor as shown inFIG. 40A. Similar todistal anchor240 described above, thedistal anchor1440 can be deployed in a similar manner using any of the delivery devices described above with respect to previous embodiments. For example, thedistal anchor1440 can be coupled to asuture1442 and removably coupled to or otherwise in operable contact with apusher1434. Thedistal anchor1440 can be delivered in the elongate configuration (see e.g.,FIG. 40A), and moved to the deployed configuration (see e.g.,FIGS. 40B and 40C) by pulling thesuture1442 proximally and/or moving thepusher1434 distally. As thedistal anchor1440 is moved distally and theopen end portion1440aexits thedistal end portion1432 of the delivery device, thedistal anchor1440 is allowed to expand (i.e., theopen end1440aopens) towards its deployed or expanded configuration, as shown inFIG. 40B.

In an alternative embodiment, a distal anchor can be configured similar to thedistal anchor1440 except that the distal anchor can be disposed on thesuture1442 such that the open end of the umbrella shaped portion is distal to the rounded distal end of the distal anchor. In such an embodiment, the rounded distal end can define a hole through which the suture can be extended and secured. The distal anchor can be formed with for example a shape-memory material such that the distal anchor has a biased expanded or deployed configuration and an elongated collapsed configuration when constrained within a delivery device. The distal anchor can be pushed or moved out of a delivery device with, for example, a pusher device. As the distal anchor exits a distal end of the delivery device, the distal anchor can transition from its elongated collapsed configuration to its expanded, deployed or biased configuration. Said another way, as the distal anchor exits the distal end of the delivery device, the open end of the distal anchor opens to its expanded or biased configuration. In this manner, the distal anchor can transition from its delivery configuration to its deployed configuration as it exits the delivery device.

In another embodiment of a distal anchor, the circumferential windings of the knot in the knotdistal anchor240 described above are replaced by an expandable distal anchor, as shown inFIGS. 41A-41D. In this embodiment, thedistal anchor1540 includeselongate members1540bwithfree ends1540aand astopper receiving section1591.FIG. 41A illustrates thedistal anchor1540 in an elongated delivery configuration and disposed within a lumen defined by adistal end portion1532 of a delivery device such that the free ends1540aofelongate members1540bare disposed proximal to thestopper receiving section1591 of thedistal anchor1540.FIG. 41B illustrates thedistal anchor1540 in the elongated delivery configuration.FIGS. 41C and 41D illustrate thedistal anchor1540 in a deployed configuration. In this embodiment, a distal end portion of thesuture1542 includes astopper1590 and thestopper receiving section1591 of thedistal anchor1540 is configured to cooperatively mate with thestopper1590. During delivery of thedistal anchor1540, the interior walls of thedistal end portion1532 can retain thedistal anchor1540 in its elongated delivery configuration when thedistal anchor1540 is disposed within a lumen defined by thedistal end portion1532, as shown inFIG. 38A. Similar todistal anchor240 described above, thedistal anchor1540 can be deployed in a similar manner using any of the delivery devices described above with respect to previous embodiments. For example, thedistal anchor1540 can be coupled to asuture1542 and removably coupled to or otherwise in operable contact with apusher1534. Thedistal anchor1540 can be delivered in the elongated configuration (see e.g.,FIG. 41A) and moved to the deployed configuration (see e.g.,FIGS. 41B and 41C) by pulling thesuture1542 proximally and/or moving thepusher1534 distally (see e.g.,FIG. 41C). In this manner, thestopper1590 of thesuture1542 can be moved into contact with thestopper receiving section1591, and thestopper1590 and thestopper receiving section1591 can collectively facilitate the transition of thedistal anchor1540 from the elongated delivery configuration to the expanded deployed configuration.

In an alternative embodiment, a distal anchor can be configured similar to thedistal anchor1540 except that the distal anchor can be disposed on thesuture1542 such that the free ends of the elongate members are distal to the stopper receiving section. In such an embodiment, the distal anchor can be formed with for example a shape-memory material such that the distal anchor has a biased expanded or deployed configuration and an elongated collapsed configuration when constrained within a delivery device. The distal anchor can be pushed or moved out of a delivery device with, for example, a pusher device. As the distal anchor exits the delivery device, a distal end of the distal anchor can transition from its elongated collapsed configuration to its expanded, deployed or biased configuration. Said another way, as the distal anchor exits the distal end of the delivery device, the free ends of the elongate members can extend radially towards the deployed or biased configuration of the distal anchor. In this manner, the distal anchor can transition from its delivery configuration to its deployed configuration as it exits the delivery device.

Thedistal anchor1540 can be formed of any suitable material, such as, for example a malleable stainless steel, a shape memory or superelastic alloy, or a polymer. One such polymer, for example, can include polyaryletherketones (PAEKs) such as polyetheretherketone (PEEK). Optionally, in some embodiments, a distal anchor can include or be coupled to a material (e.g., a fabric and/or polymer) that is configured to distribute an anchor load, cover and/or seal the hole made in the leaflet, and/or promote ingrowth or an otherwise desirable biological response when the distal anchor is disposed within a heart. For example, as illustrated inFIGS. 42A and 42B, thedistal anchor1540 ofFIGS. 41A-41D can have such amaterial1592 coupled thereto. For example, in some embodiments, thematerial1592 can extend between theelongate members1540band beyond the free ends1540aof thedistal anchor1540, as shown inFIG. 42A. In some embodiments, thematerial1592 can be sized and shaped to replicate or nearly replicate the size and shape of theelongate members1540bof thedistal anchor1540, as shown inFIG. 42B.

In another embodiment of a distal anchor, the circumferential windings of the knot in the knotdistal anchor240 described above are replaced by an expandable distal anchor, as shown inFIGS. 43A-43C.FIG. 43A illustrates a distal end portion of thedistal anchor1640 in a deployed configuration.FIG. 43B illustrates a proximal end portion of thedistal anchor1640 in the deployed configuration.FIG. 43C illustrates in partial cross-section thedistal anchor1640 in the deployed configuration. In this embodiment, a distal end portion of thesuture1642 includes astopper1690. Aradial support member1694 is coupled and disposed proximal to the proximal end portion of thedistal anchor1640. Theradial support member1694 can prevent or otherwise limit thedistal anchor1640 from undesirably flipping or deflecting (1) beyond a plane defined by thestopper1690, and/or (2) distal to thestopper1690. Theradial support member1694 can be made of any suitable material sufficient to provide radial support, such as, for example, a non-elastic material. In addition, as shown best inFIG. 43C, thedistal anchor1640 is pre-configured to have a slight angle.

Similar todistal anchor240 described above, thedistal anchor1640 can be deployed in a similar manner using any of the delivery devices described above with respect to previous embodiments. For example, thedistal anchor1640 can be coupled to thesuture1642 and removably coupled to or otherwise in operable contact with a pusher (not shown). Thedistal anchor1640 can be delivered in the elongated configuration (not shown) and moved to the deployed configuration by pulling thesuture1642 proximally and/or moving the pusher (not shown) distally, as shown inFIGS. 43A-43C. In this manner, thestopper1690 of thesuture1642 can be moved into contact with the distal end portion of the distal anchor940, and as a result, can collectively facilitate the transition of thedistal anchor1640 from the elongated delivery configuration (not shown) to the expanded deployed configuration. Although not shown, in some embodiments, thedistal anchor1640 can include radial stiffening members in addition to or instead being coupled to theradial support member1694.

In another embodiment of a distal anchor, the circumferential windings of the knot in the knotdistal anchor240 described above are replaced by an expandable braid, as shown inFIGS. 44A-44E.FIG. 44A illustrates the expandable braiddistal anchor1740 in an elongated delivery configuration,FIG. 44B illustrates thedistal anchor1740 in the elongated delivery configuration with reference to a valve leaflet L, andFIG. 44C illustrates thedistal anchor1740 in cross-section in the elongated delivery configuration.FIG. 44D illustrates thedistal anchor1740 in an expanded or deployed configuration with reference to a valve leaflet L, andFIG. 44E illustrates in cross-section thedistal anchor1740 in the deployed configuration. In this embodiment, the expandable braiddistal anchor1740 has adistal portion1745, aproximal portion1756, and adistal collar1795 disposed therebetween. Thedistal anchor1740 also includes aproximal collar1796 disposed proximal to theproximal portion1756 of thedistal anchor1740. Similar to the knotdistal anchor240 described above, thedistal anchor1740 can be deployed in a similar manner using any of the delivery devices described above with respect to previous embodiments. For example, thedistal anchor1740 can be coupled to asuture1742. Thedistal anchor1740 can be delivered in the elongate configuration and moved to the deployed configuration by pulling thesuture strands1742 proximally to cause the braideddistal portion1745 and the braidedproximal portion1756 to expand radially, as shown inFIGS. 44D and 44E.

Prior to deployment of the expandable braiddistal anchor1740, thedistal collar1795 can be aligned with and disposed at least partially within the hole formed in the leaflet L, as shown inFIG. 44B. In this manner, when deployed (radially expanded), thedistal portion1745 of thedistal anchor1740 will be disposed on the distal side of the leaflet L (e.g., within the atrium of the heart), and the proximal portion1746 of thedistal anchor1740 will be disposed on the proximal side of the leaflet L (e.g., within the ventricle of the heart), as shown inFIG. 44D. Deployment of thedistal portion1745 and the proximal portion1746 can be initiated in stages. For example, deployment of thedistal portion1745 can be initiated while the proximal portion1746 is in the elongated delivery configuration, and deployment of the proximal portion1746 can be initiated after thedistal portion1745 has transitioned into the deployed configuration.

Further to this example, in use, thedistal anchor1740 can be inserted into the atrium of the heart and thedistal portion1745 can be deployed within the atrium. Next, thesuture1742 can be pulled proximally such that a proximal side surface of thedistal portion1745 of thedistal anchor1740 is brought into contact with an atrial side of the heart valve leaflet L. In this manner, thedistal portion1745 can be manipulated into a desirable position before the proximal portion1746 of thedistal anchor1740 is deployed. Once thedistal portion1745 is suitable positioned against the valve leaflet L, the proximal portion1746 of thedistal anchor1740 can be deployed such that a distal side surface of the proximal portion1746 is brought into contact with a ventricle side of the valve leaflet L, thereby securing the leaflet L between thedistal portion1745 and the proximal portion1746.

Although not shown, in some embodiments, thedistal anchor1740 can include a locking mechanism configured to lock, bias, or otherwise maintain thedistal anchor1740 in its expanded deployed configuration. Further, in some embodiments, thedistal portion1745 and the proximal portion1746 can be formed of shape memory or superelastic material such that its expanded deployed configuration is its unbiased configuration.

In another embodiment of a distal anchor, the circumferential windings of the knot in the knotdistal anchor240 described above are replaced by a single flexible tube, as shown inFIGS. 45A-45C.FIG. 45A illustrates thedistal anchor1840 in an elongated delivery configuration, andFIGS. 45B and 45C illustrate thedistal anchor1840 in a deployed configuration, in side view and perspective view, respectively. In this embodiment, theflexible tube1840 has adistal portion1845, and aproximal portion1856, and amedial portion1846 disposed therebetween. Each portion is separated by a hinge section, i.e., afirst hinge section1897 is disposed between thedistal portion1845 and themedial portion1846, and asecond hinge section1898 is disposed between themedial portion1846 and theproximal portion1856. Thesuture1842 includes astopper1890 at its distal end, and extends therefrom through a first aperture AP1, a second aperture AP2 and a third aperture AP3, each of which is defined by theflexible tube1840, as shown inFIGS. 45A-45C.

Similar to the knotdistal anchor240 described above, thedistal anchor1840 can be deployed in a similar manner using any of the delivery devices described above with respect to previous embodiments. Thedistal anchor1840 can be delivered in the elongate configuration and moved to the deployed configuration by pulling thesuture strand1842 proximally to deflect theportions1845,1846,1156 about theirrespective hinge sections1897,1898, as shown inFIGS. 45B and 45C. In this manner, theportions1845,1846,1856 are drawn towards each other (or folded onto one another) to form the expanded deployed configuration.

Thedistal anchor1840 can be formed of any suitable material, e.g., ePFTE or a similar biocompatible polymer. In an alternative embodiment, instead of a single flexible tube1844, theanchor1840 can be formed of separate portions and then coupled together. Further, in an alternative embodiment, instead of three portions (i.e., distal, proximal, medial), theanchor1840 can include any suitable number of portions (e.g., a single portion or four or more portions).

In another embodiment of a distal anchor, the circumferential windings of the knot in the knotdistal anchor240 described above are replaced by a hinged tube, as shown inFIGS. 46A and 43B.FIG. 46A illustrates thedistal anchor1940 in an elongated delivery configuration, andFIG. 46B illustrates schematically thedistal anchor1940 in a deployed configuration. In this embodiment, the hingedtube1940 has adistal portion1945, and aproximal portion1956, and hinge sections HS to facilitate deployment, deflection or bending of thedistal portion1945 and theproximal portion1956 at desirable sections of thedistal anchor1940. A distal end portion of an elongated tube1999 is fixedly coupled to a distal end of thedistal portion1945 of thedistal anchor1940, and extends through a lumen defined by thedistal anchor1940, out a proximal end of theproximal portion1945 of thedistal anchor1940, and then coupled to asuture1942, as shown inFIG. 46A. Similar to the knotdistal anchor240 described above, thedistal anchor1940 can be deployed in a similar manner using any of the delivery devices described above with respect to previous embodiments. For example, thedistal anchor1940 can be delivered in the elongate configuration and moved to the deployed configuration by pulling thesuture strand1942 proximally, and thereby similarly moving the elongated tube1999 proximally with thesuture strand1942, to deflect the hingedtube1940 laterally with respect to the hinge sections HS to form the deployed or expanded configuration, as shown inFIG. 46B.

While some of the distal anchors described above as being delivered to a left ventricle of a heart, piercing a native mitral valve leaflet from the ventricular side to the atrial side, deploying the distal anchor on the atrial side of the leaflet, and anchoring the distal anchor to an apex region of the heart, in other instances, the distal anchors described above can be delivered and deployed via other suitable methods, e.g., transfemorally, transatrially and/or via an inferior vena cava (IVC). For example, in some embodiments, one or more native valve leaflets can be pierced from the atrial side to the ventricular side, and the distal anchor can be delivered from the atrial side to the ventricular side and deployed in the ventricle. In such embodiments, in some instances, the distal anchor can be attached or otherwise coupled to (e.g., via a suture) a second distal anchor (e.g., deployed at a second leaflet). In some instances, the distal anchor can be anchored to the apical region of the heart by routing a suture attached to the anchor through the area or void between the leaflets from the atrial side to the ventricular side.

It should be understood that the distal anchors described herein can be delivered and deployed using any of the delivery devices described herein or any other suitable delivery device. While some embodiments described herein have included delivery devices configured to deploy a bulky knot distal anchor, in other embodiments, those delivery devices can be configured to deliver and deploy any suitable distal anchor, such as, for example, any of the distal anchors illustrated inFIGS. 35-46B.

It should be understood that although in various embodiments described herein the puncture member was shown and described as defining an internal lumen through which an artificial chorda can extend, in other embodiments, any of the delivery devices described herein can include a puncture member having a solid shaft along which an artificial chorda can extend. In such embodiments, for example, a proximal end portion of the artificial chorda can be coupled to an actuator of the delivery device.

Although in various embodiments described herein, such as, for example, the embodiments described with reference to full forward deployment sequences, a portion of the suture is illustrated and described as being coupled to the actuator and/or a suture catch, in alternative embodiments, a portion (e.g., a proximal end portion) of the suture can be coupled (e.g., fixedly coupled) to any suitable portion of the delivery device. For example, in some embodiments, a proximal end portion of the suture can be fixedly coupled to the handle of the delivery device.

In various embodiments described herein, to allow the distal anchor to slide relative to the actuator, when the suture is loaded within the delivery device, there is slack in the suture between the distal anchor and the suture lock within the suture catch (or other location at which the proximal end portion of the suture is fixedly coupled). In alternative embodiments, in addition to or instead of the slack, any suitable mechanism can be used. For example, in some embodiments, a spring or the like can be coupled to the suture and a portion of the handle of the delivery device such that the distal anchor can slide as discussed in further detail herein.

It should be understood that although in various embodiments described herein the delivery device includes an outer tube and an end effector, in other embodiments, a delivery device can be constructed similar to and can function similar to any of the delivery devices described herein, except the delivery device does not include an outer tube and an end effector. In such embodiments, for example, in some instances, the delivery device can deliver and deploy a distal anchor in cooperation with a separate device or devices configured to function similar to or the same as the outer tube and/or end effectors described herein. For example, in some instances, an introducer valve, sheath, catheter or the like can be used. In such instances, the puncture member and/or pusher device can be movably disposed within the introducer valve as the puncture member and/or pusher device are used to delivery and deploy the distal anchor. In some embodiments, an end effector can be disposed at a distal end portion of the introducer valve.

While various embodiments of delivery devices have been described above with respect to procedures conducted by a human operator (e.g., a surgeon), in some embodiments, the delivery device can be configured to operate in conjunction with robotics used in, for example, robotic assisted surgery. Similarly stated, a robotic assisted procedure can be performed using the delivery devices described above.

While various embodiments have been described above with respect to a trans-apical approach and via a left atrium of a heart, in some embodiments, an anchor-tether apparatus can be delivered transfemorally (e.g., using a catheter). In some instances, for example, native mitral valve leaflets can be pierced from an atrial side to a ventricular side of the leaflets, and the free ends of the sutures can be secured together (e.g., an edge-to-edge repair). In other instances, as another example, after piercing a native mitral valve leaflet from the atrial side to the ventricular side of the leaflet, the free end of the suture can extend beyond the free edge of the leaflet towards the ventricle and be secured to the ventricular wall or through the apex of the heart and secured outside of the heart, as described with respect to previous embodiments. As a further example, in some instances, the anchor-tether apparatus can be delivered transfemorally, and the delivery device can pierce the native mitral valve leaflet from the ventricular side to the atrial side, and the sutures can be secured together or routed into the ventricle and secured to the ventricle wall.

While various embodiments have been described above, it should be understood that they have been presented by way of example only, and not limitation. Where methods described above indicate certain events occurring in certain order, the ordering of certain events may be modified. Additionally, certain of the events may be performed concurrently in a parallel process when possible, as well as performed sequentially as described above.

Where schematics and/or embodiments described above indicate certain components arranged in certain orientations or positions, the arrangement of components may be modified. While the embodiments have been particularly shown and described, it will be understood that various changes in form and details may be made. Any portion of the apparatus and/or methods described herein may be combined in any combination, except mutually exclusive combinations. The embodiments described herein can include various combinations and/or sub-combinations of the functions, components and/or features of the different embodiments described.

Depending on the embodiment, certain acts, events, or functions of any of the processes described herein can be performed in a different sequence, may be added, merged, or left out altogether. Thus, in certain embodiments, not all described acts or events are necessary for the practice of the processes. Moreover, in certain embodiments, acts or events may be performed concurrently.

Conditional language used herein, such as, among others, “can,” “could,” “might,” “may,” “e.g.,” and the like, unless specifically stated otherwise, or otherwise understood within the context as used, is intended in its ordinary sense and is generally intended to convey that certain embodiments include, while other embodiments do not include, certain features, elements and/or steps. Thus, such conditional language is not generally intended to imply that features, elements and/or steps are in any way required for one or more embodiments or that one or more embodiments necessarily include logic for deciding, with or without author input or prompting, whether these features, elements and/or steps are included or are to be performed in any particular embodiment. The terms “comprising,” “including,” “having,” and the like are synonymous, are used in their ordinary sense, and are used inclusively, in an open-ended fashion, and do not exclude additional elements, features, acts, operations, and so forth. Also, the term “or” is used in its inclusive sense (and not in its exclusive sense) so that when used, for example, to connect a list of elements, the term “or” means one, some, or all of the elements in the list. Conjunctive language such as the phrase “at least one of X, Y and Z,” unless specifically stated otherwise, is understood with the context as used in general to convey that an item, term, element, etc. may be either X, Y or Z. Thus, such conjunctive language is not generally intended to imply that certain embodiments require at least one of X, at least one of Y and at least one of Z to each be present.

It should be appreciated that in the above description of embodiments, various features are sometimes grouped together in a single embodiment, figure, or description thereof for the purpose of streamlining the disclosure and aiding in the understanding of one or more of the various inventive aspects. This method of disclosure, however, is not to be interpreted as reflecting an intention that any claim require more features than are expressly recited in that claim. Moreover, any components, features, or steps illustrated and/or described in a particular embodiment herein can be applied to or used with any other embodiment(s). Further, no component, feature, step, or group of components, features, or steps are necessary or indispensable for each embodiment. Thus, it is intended that the scope of the inventions herein disclosed and claimed below should not be limited by the particular embodiments described above, but should be determined only by a fair reading of the claims that follow.

Claims (21)

What is claimed is:

1. An apparatus, comprising:

a handle;

one or more actuators operably coupled to the handle;

an elongate outer tube projecting from the handle;

a pusher device defining a lumen and disposed at least partially within the elongate outer tube and the handle;

a puncture member coupled to the one or more actuators and at least partially disposed within the lumen of the pusher device; and

a tissue anchor disposed in a delivery configuration around a distal portion of the puncture member, the tissue anchor being associated with one or more suture tails that are coupled to the handle and extend through a lumen of the puncture member;

wherein the one or more actuators are configured to be actuated to cause (1) the puncture member to move distally to an extended position in which the puncture member projects from a distal opening of the elongate outer tube a preset distance, and (2) the pusher device to move distally such that the tissue anchor is pushed distally off of a distal end of the puncture member by a distal end of the pusher device while the puncture member is in the extended position.

2. The apparatus ofclaim 1, wherein, when the puncture member is moved distally to the extended position:

the tissue anchor is disposed at least partially within the elongate outer tube in the delivery configuration; and

the distal end of the pusher device is disposed in the elongate outer tube.

3. The apparatus ofclaim 1, further comprising an end effector disposed at a distal end portion of the elongate outer tube, the end effector having a diameter greater than a diameter of the distal end portion of the elongate outer tube.

4. The apparatus ofclaim 1, wherein:

the tissue anchor is disposed in an elongated coiled configuration when in the delivery configuration;

the one or more actuators are configured such that the one or more suture tails are pulled proximally and the tissue anchor is moved from the elongated coiled configuration to a deployed configuration when the one or more actuators are actuated; and

the tissue anchor is disposed in a coiled knot configuration when in the deployed configuration.

5. The apparatus ofclaim 1, wherein:

the one or more actuators comprise a plunger;

the plunger is movably coupled to the handle; and

the puncture member is releasably coupled to the plunger.

6. The apparatus ofclaim 1, wherein the preset distance is between about 0.2 inches to about 0.3 inches.

7. The apparatus ofclaim 1, wherein:

the preset distance is a first preset distance;

the one or more actuators are configured to be actuated such that the pusher device is moved distally a second preset distance from the distal opening of the elongate outer tube;

the first preset distance being about 0.2 inches to about 0.3 inches; and

the second preset distance being between about 0.6 inches to about 0.7 inches.

8. The apparatus ofclaim 1, further comprising a lock configured to:

prevent actuation of the one or more actuators when the lock is engaged; and

allow actuation of the one or more actuators when the lock is disengaged.

9. The apparatus ofclaim 1, wherein the one or more actuators are configured to be actuated to cause the pusher device to further advance distally to cause the tissue anchor to transition to a deployed configuration.

10. The apparatus ofclaim 9, wherein:

in the delivery configuration, the tissue anchor has a first diameter; and

in the deployed configuration, the tissue anchor has a second diameter that is greater than the first diameter.

11. The apparatus ofclaim 9, wherein:

in the delivery configuration, the tissue anchor has a first width; and

in the deployed configuration, the tissue anchor has a second width that is greater than the first width.

12. An apparatus, comprising:

a handle;

one or more actuators operably coupled to the handle;

an elongate outer tube projecting from the handle;

a pusher device defining a lumen and disposed at least partially within the elongate outer tube and the handle;

a needle coupled to the one or more actuators and at least partially disposed within the lumen of the pusher device; and

an anchor disposed on the needle in a delivery configuration;

wherein:

the anchor is associated with one or more suture strands that extend through a lumen defined by the needle;

the one or more actuators are configured to be actuated at a first time period to cause (1) the needle to advance distally a preset distance beyond a distal end of the elongate outer tube, and (2) the pusher device to advance distally to push the anchor distally beyond a distal end of the needle; and

the one or more actuators are configured to be actuated at a second time period after the first time period to cause the anchor to transition from the delivery configuration to a deployed configuration.

13. The apparatus ofclaim 12, further comprising an end effector disposed at the distal end of the elongate outer tube, the end effector having a diameter greater than a diameter of the elongate outer tube.

14. The apparatus ofclaim 12, wherein:

in the delivery configuration, the anchor has a first diameter; and

in the deployed configuration, the anchor has a second diameter that is greater than the first diameter.

15. The apparatus ofclaim 12, wherein:

in the delivery configuration, the anchor has a first width; and

in the deployed configuration, the anchor has a second width that is greater than the first width.

16. The apparatus ofclaim 12, wherein the one or more suture strands are configured to function as an artificial chorda.

17. The apparatus ofclaim 12, wherein the preset distance is about 0.2 inches to about 0.3 inches.

18. The apparatus ofclaim 12, further comprising a lock configured to:

prevent actuation of the one or more actuators when the lock is engaged; and

allow actuation of the one or more actuators when the lock is disengaged.

19. The apparatus ofclaim 12, wherein when the one or more actuators are actuated at the first time period, both the pusher device and the needle are moved distally through a lumen of the elongate outer tube.

20. The apparatus ofclaim 12, wherein:

the anchor is disposed in an elongated coiled configuration when in the delivery configuration;

when the one or more actuators are actuated at the second time period, the one or more suture strands are pulled proximally to cause the anchor to transition from the elongated coiled configuration to the deployed configuration; and

the anchor is disposed in a coiled knot configuration when in the deployed configuration.

21. The apparatus ofclaim 20, wherein:

the one or more actuators comprise a needle hub and a pusher hub;

the needle hub and the pusher hub are movably coupled to the handle;

the pusher device is coupled to the pusher hub; and

the needle is coupled to the needle hub.

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